EUTECNIQ Sciences

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Quality system Architecture: proposal Rules: cited

One quality management system would sit over distinct compliance programs, and each program keeps its own scope, records and release decision

EUTECNIQ would test, develop and later manufacture; each activity falls under a different rule. This page maps rule to work, the procedures needed, lot release and what the facility would not do.

4compliance programs under one system: 21 CFR 111, 21 CFR 117, ISO/IEC 17025, cosmetics
1,938Part 111 citations in FDA's fiscal 2025 Form 483 data
36–39%of each year's Part 111 citations fell in Subpart E, specifications, fiscal 2021–2025
70Part 111 sections cited at least once in fiscal 2025

Status. No quality system is in operation; EUTECNIQ has no facility, FDA registration, accreditation or procedures. Regulatory text as of October 22, 2026; not legal advice.

Three distinctions the design depends on

  1. One system, several rulebooks. A shared management layer does not make 21 CFR 111, 21 CFR 117 and cosmetic obligations interchangeable.
  2. Accreditation is per scope. ISO/IEC 17025 covers the tests listed for one laboratory. It is not GMP.
  3. No drug manufacturing. Drug GMP (21 CFR Parts 210 and 211) is outside the plan, and Part 111 compliance does not cover drugs.
Market by market

Each product category and activity answers to its own rule

Six pairs the quality design keeps apartRegulatory distinctions
Six things the quality system would not equate: accreditation and GMP, Part 111 and drug GMP, registration and approval, cosmetic listing and approval, an integrated system and interchangeable regimes, stability testing and validated shelf lifeISO/IEC 17025 accreditation≠GMP compliancePart 111 compliance≠Drug GMP (21 CFR 210 and 211)FDA facility registration≠FDA approvalCosmetic registration andlisting≠FDA approvalIntegrated managementsystem≠Interchangeable regulatoryregimesStability testing≠Validated shelf life
Distinctions drawn from the rules cited on this page (21 CFR 111, 117, 210–211; ISO/IEC 17025; MoCRA), as of October 22, 2026; not legal advice.
Text version of the six distinctions
  • ISO/IEC 17025 accreditation≠GMP compliance
  • Part 111 compliance≠Drug GMP (21 CFR 210 and 211)
  • FDA facility registration≠FDA approval
  • Cosmetic registration and listing≠FDA approval
  • Integrated management system≠Interchangeable regulatory regimes
  • Stability testing≠Validated shelf life

Sources: eCFR, 21 CFR Parts 1 (Subparts H and L), 50, 56, 58, 111, 117, 170, 210, 211 and 312, current to Oct 21, 2026; 21 U.S.C. 379aa-1 (FD&C Act § 761); 21 U.S.C. 351; 21 U.S.C. 364–364d (MoCRA); FDA MoCRA page (content current Aug 10, 2026); 91 FR 51834 (Aug 11, 2026); 80 FR 55908, Response 196 (Sept 17, 2015); ILAC-P8:11/2023. Not legal advice.

Explanation, details and sources

Each proposed activity, the rule that would govern it, its core obligations and EUTECNIQ's planned position. Status as of October 22, 2026.

Activity or marketGoverning rule and statusCore obligationsFDA approval?Planned EUTECNIQ position
Finished dietary supplements (made, packaged, labeled or held)21 CFR Part 111 Final regulationSpecifications for components, in-process steps and finished batches (111.70); identity test of each dietary-ingredient lot (111.75); quality-control review and disposition (111.87, 111.123); master and batch records (111.205–111.260); reserve samples (111.83); complaints (Subpart O). The label's responsible person reports serious adverse events within 15 business days and keeps records for 6 years (FD&C Act § 761).No. FDA does not approve dietary supplements.Supplement packaging and manufacturing from Phase II–III, after their gates; testing for Part 111 customers from Phase I.
Dietary ingredients and extracts sold only to other manufacturers21 CFR Part 117 Final regulationCurrent good manufacturing practice (Subpart B); a written food safety plan with hazard analysis and preventive controls (117.126–117.135); corrective actions (117.150); a supply-chain program (Subpart G), unless an exemption applies. The 117.5(e) exemption covers supplement manufacture under Part 111, not dietary-ingredient manufacture.No.Ingredient operations from Phase II (pilot extraction). A site making both supplements and ingredients would run Part 111 and Part 117 programs side by side.
Conventional food and beverage ingredients21 CFR Part 117 Final; GRAS or food-additive status (21 CFR 170.30) Final; mandatory GRAS notification Proposed Aug 11, 2026Manufacturing as above. The substance must be GRAS for its intended use, an approved food additive or otherwise authorized. Self-affirmed GRAS conclusions remain lawful today.Food additives need FDA approval. GRAS notices receive response letters, not approvals.Development and testing services; any manufacturing scope would be decided later.
Cosmetics and personal careFD&C Act Chapter VI as amended by MoCRA (2022) Statute in effect; cosmetic GMP rule Not yet proposedFacility registration and product listing; adequate substantiation of safety; serious adverse event reports within 15 business days; adverse-event records kept 6 years (3 for certain small businesses). No proposed cosmetic GMP rule had been published as of October 22, 2026; FDA's draft cosmetic GMP guidance and ISO 22716 are the working references.No. Registration and listing are not approval.Development and testing services. Any cosmetic manufacturing would align with FDA's draft cosmetic GMP guidance and ISO 22716.
Contract analytical testingISO/IEC 17025:2017 Voluntary accreditationCompetence, impartiality and consistent operation for the tests on the laboratory's scope: method validation or verification, measurement uncertainty, traceability, handling of test items and reporting. A laboratory may claim accreditation only for work inside its scope.Not an FDA matter. Accreditation bodies such as A2LA or ANAB grant it.Phase I laboratory. Application for a first scope targeted for Q1 2028 (proposal). EUTECNIQ holds no accreditation.
Imported ingredients21 CFR Part 1, Subpart L (FSVP); 1.511 for supplements Final regulationVerify foreign suppliers. Reduced requirements apply only when the importer or its customer is the Part 111 firm that tests the incoming material.No.Planned with the global ingredients function.
Facility registration21 CFR Part 1, Subpart H Final regulationRegister before manufacturing, processing, packing or holding food, which includes dietary supplements and dietary ingredients; renew every other year, October 1 to December 31 of even-numbered years.No. Registration is not approval.Planned before regulated operations begin.
Nonclinical safety studies21 CFR Part 58 (GLP) Final regulationApplies to studies that support listed applications, such as food additive petitions and INDs. FDA's current NDI guidance does not require GLP.Not applicable.Qualified CROs; pivotal studies designed to GLP standards where appropriate.
Human studies21 CFR Parts 50 and 56; Part 312 for disease endpoints Final regulationInformed consent and IRB review. A study of a supplement's effect on disease needs an IND; a structure or function study does not.Not applicable.Qualified clinical research organizations.
Drug manufacturing, including clinical supplies for IND studies21 CFR Parts 210 and 211 Final regulationDrug current good manufacturing practice. A drug made without it is adulterated (FD&C Act § 501(a)(2)(B)).Drugs require FDA approval.Out of scope. Not planned. Part 111 compliance does not cover drug manufacturing or drug batch-release testing.
Architecture

Shared procedures and people would sit above separate programs, each with its own scope and release

Shared quality-management elements over four distinct compliance programsProposal
The Part 117 exemption for supplements made under Part 111 does not extend to dietary-ingredient manufacture, so an extraction operation selling ingredients needs its own hazard analysis and preventive controls unless another exemption applies. Testing used to release clinical or commercial drug batches would require drug GMP laboratory controls (21 CFR 211), which are not in the plan.21 CFR 117.5(e); 80 FR 55908, Response 196; 21 CFR 111.1; 21 CFR 210.1, 211.1.

An integrated management system would share procedures and people across programs. It would not make distinct regulatory regimes interchangeable.

Explanation, details and sources

The shared layer avoids duplicate procedures for training, documents, deviations and data. Each program below it keeps its own scope, records and release decision.

Core procedures

Eight procedures would have to be written and working before the first reportable result

Eight procedures, the rules behind them, and where FDA most often finds gapsPlanned procedures
Eight planned procedures, the regulations that require the activity each implements, and FDA's fiscal 2025 Form 483 citation counts for the sections the page namesProcedure and what it would do21 CFR Part 111 (supplements)Part 117, Part 1, Part 11Good practiceFY2025 citationsMethod qualification and validationEach method shown fit for use before itsupports a decision: validation,verification or written transfer111.320 appropriate, scientificallyvalid methods–ICH Q2(R2), Q14(drug guidances,used as goodpractice)Supplier qualificationApproved-supplier list from documents,audits and confirmatory testing acrosslots; requalified on schedule and afterfailure111.75(a)(2)(ii) certificate reliance;111.75(a)(1) identity test remains117 Subpart Gsupply-chain program;1.511 FSVP–111.75(a)(2)(ii)(A)111.75(a)(2)(ii)(A): cited 45 times in FY202545Deviations, investigations and CAPADeviations, out-of-specification resultsand complaints investigated to root cause;actions tracked and checked111.113 and 111.87 material reviewand disposition; 111.553–111.570complaints117.150 correctiveactions–Change controlChanges to specifications, methods,equipment, suppliers, processes andsoftware assessed and approved byquality first111.30(d) computer-controlledoperations; 111.123(a)(1)master-record changes117.170 reanalysis aftersignificant change–Document control and trainingVersioned, approved procedures andrecords; training tied to each version; aretention schedule111.103 written QC procedures;111.605 record retentionPart 11 for electronicrecords–111.103111.103: cited 54 times in FY202554Specifications and releaseWritten specifications for everycomponent, in-process step and finishedbatch; release decided by quality controlalone111.70, 111.75, 111.87, 111.123––111.70(e)111.70(e): cited 188 times in FY2025188111.70(b)111.70(b): cited 177 times in FY2025177Contamination preventionSeparated microbiology suite, hygieniczoning, sanitation records, water quality,monitoring where the hazard analysis callsfor it111.10 hygiene; 111.15 sanitation;111.27 equipment; 111.365precautions117.35, 117.80–Traceability and data integrityUnique lot ID from receipt to distribution;LIMS and notebooks with audit trails,access control and backup111.260(d) component identifiers;111.475 distribution records;111.605(c)117.139 recall plan; Part11–Citation counts: FDA Form 483 observations under 21 CFR 111, inspections ending Oct 1, 2024 to Sept 30, 2025 (electronic system only). Bars share one scale.
Records kept 1 year past the shelf-life date or 2 years beyond distribution of the last batch (111.605). ICH Q2(R2) and Q14 are FDA final guidances for drugs (March 2024), used here as good practice; performance characteristics include specificity, working range, accuracy, precision, and detection and quantitation limits.eCFR, 21 CFR Parts 1, 11, 111 and 117, current to Oct 21, 2026; U.S. FDA, Inspection observations, FY2025 spreadsheet (Foods tab), posted Dec 16, 2025.

Each procedure is planned; none is written.

Text version of the eight procedures

Each is planned; none is written. CAPA and change control are management practices that implement the cited requirements.

Method qualification and validation

Each test method would be shown fit for its intended use before its results support a decision: validation for methods developed in house, verification for compendial or published methods, and written transfer protocols between laboratories. Performance characteristics follow ICH Q2(R2) as good practice: specificity, working range, accuracy, precision, and detection and quantitation limits.

Rule: methods must be appropriate and scientifically valid (21 CFR 111.320). ICH Q2(R2) and Q14 are FDA final guidances for drugs (March 2024), used here as good practice.

Planned

Supplier qualification

An approved-supplier list built from documents, audits and confirmatory testing across several lots, with requalification on a schedule and after any failure. A supplier's certificate of analysis would be relied on only after its results have been confirmed.

Rule: certificate reliance requires a qualified supplier and periodic reconfirmation (21 CFR 111.75(a)(2)(ii)); identity testing of each dietary-ingredient lot remains (111.75(a)(1)); supply-chain program (117 Subpart G); FSVP (1.511). FDA cited 111.75(a)(2)(ii)(A) 45 times in fiscal 2025.

Planned

Deviations, investigations and CAPA

Every deviation, out-of-specification result and complaint would be investigated to a root cause. Corrective and preventive actions (CAPA) would be tracked to closure and checked for effectiveness.

Rule: material review and disposition by quality control (21 CFR 111.113, 111.87); product complaints (111.553–111.570); corrective actions and corrections (117.150).

Planned

Change control

Changes to specifications, methods, equipment, suppliers, processes and software would be assessed for impact, approved by quality before they take effect, and documented.

Rule: changes to computer-controlled operations approved by quality control and made only by authorized personnel (21 CFR 111.30(d)); quality approval of master-record changes (111.123(a)(1)); food safety plan reanalysis after significant change (117.170).

Planned

Document control and training

Versioned, approved procedures, specifications and records, with training records tied to each procedure version and a retention schedule.

Rule: written quality-control procedures (21 CFR 111.103); records kept 1 year past the shelf-life date or 2 years beyond distribution of the last batch, with electronic records meeting Part 11 (111.605). FDA cited 111.103 67 times in fiscal 2025: 54 for not establishing these procedures and 13 for not following them.

Planned

Specifications and release

Written specifications for every component, in-process step and finished batch, and a release decision by quality control that no one else can make. The workflow is set out below.

Rule: 21 CFR 111.70, 111.75, 111.87, 111.123. Missing specifications were FDA's two most-cited supplement observations in fiscal 2025.

Planned

Contamination prevention

A separated microbiology suite; hygienic zoning between raw botanicals, laboratories and finished product; cleaning and sanitation with records; water quality controls; and environmental monitoring where the hazard analysis calls for it.

Rule: personnel hygiene (21 CFR 111.10); plant sanitation (111.15); equipment design (111.27); precautions against contamination (111.365); sanitary operations and processes and controls for food (117.35, 117.80).

Planned

Traceability and data integrity

A unique ID for every lot from receipt to distribution, with component lots written into each batch record, so a finished lot can be traced back to its inputs and forward to customers. Laboratory data would sit in a LIMS and electronic notebooks with audit trails, access control and backup.

Rule: batch records list the identifier of each component, packaging and label (21 CFR 111.260(d)); distribution records (111.475); recall plan for foods with a hazard requiring a preventive control (117.139); electronic records under Part 11 (111.605(c)).

How the proposed LIMS, audit trails and lot genealogy would work: Digital lab.

Planned
Specification and release

A lot would move forward only on a quality-control decision, at three points

Seven operations, three quality-control decisionsPart 111 requirements
Specification and release under Part 111: four operations lead to the first quality-control decision on components; manufacture and in-process monitoring lead to two more decisions, on the batch record and on release; then retention and follow-up1SetspecificationsIdentity, purity,strength,composition,contaminant limits111.702Receive andquarantineContainers andpaperworkexamined111.1553SampleEach unique lotand shipment111.804TestIdentity of everydietary ingredient;valid methods111.75, 111.320ApprovecomponentsDecision 1 · 111.155(c), 111.87RejectedNotapprovedfor useApproved5Manufacture tothe masterrecordBatch recordcompleted111.205–111.2606Monitorin-processcontrolsWhere control isnecessary111.75(b)Approve thebatch recordDecision 2 · 111.123(a)Release orrejectDecision 3 · 111.75(c), 111.123(a)(8)7Retain and follow upReserve samples and records;complaints; serious adverseevents111.83, 111.605; Subpart O; FD&C Act § 761Not approved or rejected: material review and disposition by quality control (111.113, 111.87)Specification and release under Part 111, step by step, with the three quality-control decisions1Set specificationsIdentity, purity, strength, composition, contaminantlimits111.702Receive and quarantineContainers and paperwork examined111.1553SampleEach unique lot and shipment111.804TestIdentity of every dietary ingredient; valid methods111.75, 111.320QCDecision 1: Approve components111.155(c), 111.87else reject5Manufacture to the master recordBatch record completed111.205–111.2606Monitor in-process controlsWhere control is necessary111.75(b)QCDecision 2: Approve the batchrecord111.123(a)else rejectQCDecision 3: Release or reject111.75(c), 111.123(a)(8)else reject7Retain and follow upReserve samples and records; complaints; seriousadverse events111.83, 111.605; Subpart O; FD&C Act § 761
An ingredient sold only to other manufacturers would follow the parallel Part 117 controls. A contract test result would be reported under the laboratory's own quality system and, once accredited, only within its scope.eCFR, 21 CFR 111.70–111.605, current to Oct 21, 2026; FD&C Act § 761.
Text version of the release workflow

The workflow for a finished dietary supplement under Part 111. Quality control approves components, approves the batch record and releases or rejects the batch.

  1. Set specificationsIdentity, purity, strength, composition and contaminant limits for each component, in-process step and finished batch (111.70).
  2. Receive and quarantineExamine containers and paperwork; hold components in quarantine (111.155).
  3. SampleRepresentative samples of each unique lot and shipment (111.80).
  4. TestIdentity test of every dietary ingredient; other specifications by test or a qualified supplier's certificate (111.75), using valid methods (111.320).
  5. Decision 1: approve componentsQuality control reviews results and approves or rejects each lot for use (111.155(c), 111.87).
  6. Manufacture to the master recordFollow the approved master manufacturing record and complete the batch record (111.205–111.260).
  7. Monitor in-process controlsCheck in-process specifications where control is necessary (111.75(b)).
  8. Decision 2: approve the batch recordQuality control reviews the batch record and monitoring, and makes any material-review decision (111.123(a)).
  9. Decision 3: release or rejectVerify the finished batch against product specifications (111.75(c)); quality control releases or rejects it (111.123(a)(8)).
  10. Retain and follow upReserve samples and records kept for the required period (111.83, 111.605); complaints and serious adverse events handled (Subpart O; FD&C Act § 761).
Planned milestones

Qualification milestones are tied to the work they enable, and every one is still planned

Each milestone sits before the work it unlocksPlanned
Eight planned qualification milestones, each placed under the work it must precede: Phase I laboratory results, regulated operations, Phase II ingredient operations, the first commercial release, and cosmetic manufacturing if undertakenPhase I laboratoryRegulated operationsPhase II ingredientsFirst commercial releaseQuality manual, coreprocedures andspecification templatesapprovedBefore: Any Phase I workthat produces a reportableresultEquipment qualification(installation, operational,performance) andcalibrationBefore: Each instrument'sfirst reportable resultMethod validation orverification for each testofferedBefore: The test is offered toa customerISO/IEC 17025application, first scope:botanical identity andcontaminantsBefore: Any claim ofaccreditation; targeted for Q12028FDA food facilityregistrationBefore: Manufacturing,processing, packing orholding food, includingsupplements and dietaryingredientsFood safety plan by apreventive controlsqualified individualBefore: Phase II ingredientoperationsInternal audit and mockinspectionBefore: The first commercialreleaseCosmetics, if undertakenCosmetic facility registration under MoCRABefore: Within 60 days of starting any cosmetic manufacturing, if undertakenEvery milestone is planned; none has been reached. Timing follows facility phase and the work each enables, not a calendar promise.
Proposed sequence; no milestone has been reached, and timing follows the facility phases, not a calendar.

No milestone has been reached; timing follows facility phase and the work each enables.

Text version of the milestones
MilestoneNeeded beforeStatus
Quality manual, core procedures and specification templates approvedAny Phase I laboratory work that produces a reportable resultPlanned
Equipment qualification (installation, operational and performance) and calibration programEach instrument's first reportable resultPlanned
Method validation or verification for each test offeredThe test is offered to a customerPlanned
FDA food facility registrationManufacturing, processing, packing or holding food, including supplements and dietary ingredientsPlanned
ISO/IEC 17025 application for a first scope (botanical identity and contaminants)Any claim of accreditation; targeted for Q1 2028Planned Proposal
Food safety plan by a preventive controls qualified individualPhase II ingredient operationsPlanned
Cosmetic facility registration under MoCRAWithin 60 days of starting any cosmetic manufacturing, if undertakenPlanned
Internal audit and mock inspectionThe first commercial releasePlanned
Evidence

The most frequent supplement GMP citations are missing specifications and incomplete records

Specifications led every year: Part 111 citations by subpart, fiscal 2021–2025Government data
Cells show each subpart's share of that year's Part 111 citations; click a year to sort. Subpart A drew none. Totals rose from 704 to 1,938; counts depend on how many inspections FDA completed, so shares, not counts, are compared.U.S. FDA, Inspection observations, FY2021–FY2025 Excel files (Foods sheet), downloaded Oct 24, 2026; subparts from eCFR 21 CFR 111 (Oct 22, 2026). Computed with src/modules/qual_six/compute/p111_years.py.
Data table: citations (share of year) by subpart and fiscal year
SubpartFY2021FY2022FY2023FY2024FY2025
E · Specifications and process control260 (36.9%)459 (37.7%)423 (36.1%)614 (38.8%)759 (39.2%)
F · Quality control120 (17.0%)179 (14.7%)169 (14.4%)205 (13.0%)216 (11.1%)
H · Master manufacturing record45 (6.4%)101 (8.3%)92 (7.8%)156 (9.9%)188 (9.7%)
I · Batch production record58 (8.2%)100 (8.2%)97 (8.3%)153 (9.7%)163 (8.4%)
J · Laboratory operations13 (1.8%)33 (2.7%)23 (2.0%)33 (2.1%)77 (4.0%)
D · Equipment and utensils34 (4.8%)45 (3.7%)46 (3.9%)69 (4.4%)75 (3.9%)
M · Holding and distributing34 (4.8%)63 (5.2%)72 (6.1%)63 (4.0%)72 (3.7%)
C · Physical plant and grounds17 (2.4%)35 (2.9%)27 (2.3%)53 (3.3%)67 (3.5%)
O · Product complaints32 (4.5%)50 (4.1%)48 (4.1%)45 (2.8%)66 (3.4%)
N · Returned dietary supplements19 (2.7%)42 (3.4%)53 (4.5%)48 (3.0%)65 (3.4%)
B · Personnel21 (3.0%)28 (2.3%)38 (3.2%)37 (2.3%)53 (2.7%)
K · Manufacturing operations10 (1.4%)21 (1.7%)16 (1.4%)30 (1.9%)49 (2.5%)
G · Components, packaging and labels16 (2.3%)18 (1.5%)37 (3.2%)36 (2.3%)43 (2.2%)
L · Packaging and labeling operations20 (2.8%)37 (3.0%)29 (2.5%)38 (2.4%)37 (1.9%)
P · Records and recordkeeping5 (0.7%)7 (0.6%)3 (0.3%)3 (0.2%)8 (0.4%)
All Part 111 citations7041,2181,1731,5831,938
Fiscal 2025, section by section: 1,938 citations in 70 sectionsGovernment data
Area is proportional to citations. Hover or focus a tile for the section and count.U.S. FDA, Inspection observations, FY2025 (Foods sheet); citations summed by section; computed with src/modules/qual_six/compute/p111.py.
Data table: fiscal 2025 citations by section
SubpartSectionCitations
E · Specifications and process control§ 111.70446
E · Specifications and process control§ 111.75265
E · Specifications and process control§ 111.8330
E · Specifications and process control§ 111.805
E · Specifications and process control§ 111.554
E · Specifications and process control§ 111.773
E · Specifications and process control§ 111.602
E · Specifications and process control§ 111.902
E · Specifications and process control§ 111.952
F · Quality control§ 111.10367
F · Quality control§ 111.11340
F · Quality control§ 111.10538
F · Quality control§ 111.12327
F · Quality control§ 111.12015
F · Quality control§ 111.14012
F · Quality control§ 111.1175
F · Quality control§ 111.1274
F · Quality control§ 111.1304
F · Quality control§ 111.1103
F · Quality control§ 111.1351
H · Master manufacturing record§ 111.20595
H · Master manufacturing record§ 111.21093
I · Batch production record§ 111.260103
I · Batch production record§ 111.25560
J · Laboratory operations§ 111.32031
J · Laboratory operations§ 111.31530
J · Laboratory operations§ 111.3039
J · Laboratory operations§ 111.3257
D · Equipment and utensils§ 111.2733
D · Equipment and utensils§ 111.2523
D · Equipment and utensils§ 111.3010
D · Equipment and utensils§ 111.359
M · Holding and distributing§ 111.45349
M · Holding and distributing§ 111.45511
M · Holding and distributing§ 111.4759
M · Holding and distributing§ 111.4602
M · Holding and distributing§ 111.4651
C · Physical plant and grounds§ 111.1531
C · Physical plant and grounds§ 111.1620
C · Physical plant and grounds§ 111.2012
C · Physical plant and grounds§ 111.234
O · Product complaints§ 111.55340
O · Product complaints§ 111.57015
O · Product complaints§ 111.56011
N · Returned dietary supplements§ 111.50356
N · Returned dietary supplements§ 111.5357
N · Returned dietary supplements§ 111.5102
B · Personnel§ 111.1024
B · Personnel§ 111.1215
B · Personnel§ 111.810
B · Personnel§ 111.143
B · Personnel§ 111.131
K · Manufacturing operations§ 111.36523
K · Manufacturing operations§ 111.36013
K · Manufacturing operations§ 111.3539
K · Manufacturing operations§ 111.3752
K · Manufacturing operations§ 111.3551
K · Manufacturing operations§ 111.3701
G · Components, packaging and labels§ 111.15522
G · Components, packaging and labels§ 111.15311
G · Components, packaging and labels§ 111.1604
G · Components, packaging and labels§ 111.1804
G · Components, packaging and labels§ 111.1651
G · Components, packaging and labels§ 111.1701
L · Packaging and labeling operations§ 111.40316
L · Packaging and labeling operations§ 111.41512
L · Packaging and labeling operations§ 111.4105
L · Packaging and labeling operations§ 111.4304
P · Records and recordkeeping§ 111.6106
P · Records and recordkeeping§ 111.6052
The six most frequent 21 CFR 111 citations in FDA Form 483 observations, fiscal 2025Government data
Show data
Cited sectionRequirementCitations
111.70(e)Specifications for each finished batch188
111.70(b)Specifications for each component177
111.260Contents of the batch production record103
111.210Contents of the master manufacturing record93
111.205(a)Master manufacturing record prepared75
111.75(a)(1)(i)Identity test of each dietary-ingredient lot66
Counts of citations in Form 483s issued from FDA's electronic system for inspections ending October 1, 2024 to September 30, 2025. FDA notes the data do not include every 483 issued, because some were prepared manually. Counts are per FDA citation (one standardized observation text tied to a section); a section can carry several citations, so a ranking by section can differ slightly.U.S. FDA, Inspection observations, FY2025 spreadsheet (Foods tab), posted Dec 16, 2025. fda.gov

Subpart E, specifications, drew 36–39% of all Part 111 citations in every fiscal year from 2021 to 2025.

Explanation, details and sources

FDA's fiscal 2025 inspection data show where supplement firms most often fall short: the problems a specification, analytics and records system is meant to prevent.

The top two are missing or inadequate specifications; ranks three to five are batch and master manufacturing records; identity testing of incoming dietary ingredients is sixth.

Every dietary-ingredient lot needs at least one appropriate identity test or examination (21 CFR 111.75(a)(1)(i)). A supplier's certificate may replace other component tests only after the supplier is qualified.

FDA's citation codes changed over the period (for example, 111.70(b)(1) and (b)(2) were reported as 111.70(b) in fiscal 2025), so trends are compared by subpart. The files cover Form 483s from FDA's electronic system only. The statistics behind specification limits are on Quality and Six Sigma. The same FDA data appear with market context on Competitive landscape. A section-level heat map going back to fiscal 2019 is on Deliverables; record and data-integrity controls (LIMS, Part 11, audit trails) are on Digital lab.

Regulatory context

The same plant can follow different regulatory pathways, each with its own manufacturing rule

Intended use, not the plant, decides the category; the category decides the manufacturing rule and whether FDA approval exists at all.

Four pathways for the same plant, depending on intended use

Show the table (5 rows)
RequirementConventional foodDietary supplementBotanical drugDrug (isolated compound)
Before marketingGRAS status or food-additive approval; mandatory GRAS notification proposed Aug 11, 2026No FDA approval; a new dietary ingredient generally needs notification at least 75 days before marketingIND, controlled trials and an NDA under FDA's botanical drug guidanceIND, controlled trials and an NDA
Manufacturing21 CFR Part 11721 CFR Part 111 (ingredients sold to manufacturers: Part 117)Drug GMP, 21 CFR 210–211Drug GMP, 21 CFR 210–211
ClaimsFood labeling rules (21 CFR Part 101)Structure/function statements with the required disclaimer; FDA notified within 30 days of first marketingApproved labeling onlyApproved labeling only
After marketingGeneral food-safety dutiesSerious adverse events reported within 15 business days; records kept 6 yearsDrug postmarketing safety reportingDrug postmarketing safety reporting
FDA approval?No for the food; food additives need approvalNoYesYes
Terms and caveats

"Nutraceutical" and "functional food" are commercial terms, not legal categories. Pharmaceutical-grade practice does not make a supplement FDA-approved. Proposed rules may change before they are final. Not legal advice.

21 CFR 101.93, 111, 117, 170.30, 190.6, 210–211; 91 FR 51834 (Aug 11, 2026); FD&C Act § 761 (21 U.S.C. 379aa-1); FDA, Botanical Drug Development: Guidance for Industry (December 2016).

How FDA has responded to new dietary ingredient notifications

Share of NDI notifications acknowledged without objectionTrade-press analysis of FDA data
Show data
PeriodResponsesAcknowledged without objection
1995–20201,07836.5%
Fiscal 20224230 (71%)
Fiscal 20234427 (61%)
Secondary analyses of FDA notification records published by a trade outlet; not FDA statistics. An acknowledgment without objection is not FDA approval or an FDA finding of safety.J. Long, Natural Products Insider / SupplySide (Dec 18, 2020; Dec 12, 2023). 2020 analysis · FY2023 analysis
Explanation, details and sources

Over the long run most notifications drew objections or were incomplete. The rate was higher in fiscal 2022 and 2023, which is consistent with, but does not prove, a benefit from complete, well-characterized dossiers.

A notification is due at least 75 days before a new dietary ingredient enters interstate commerce (21 CFR 190.6). FDA finalized key identity and safety guidance in October 2026; strategy is on the NDIN page.

Testing or quality questions about a botanical ingredient

EUTECNIQ is in formation and offers no services yet; early conversations help shape scope.

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