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21 CFR CLAUSE ENCYCLOPEDIA · 40 ENRICHED CITATION HUBS (1,620 OFFICIAL TEMPLATES)

FDA 21 CFR Citation Encyclopedia & Free SOP Clauses

Every federal cGMP clause cited on FDA Form 483s translated into plain English — with historical citation frequency, inspector red-flag triggers, CAPA remediation playbooks, and copy-paste SOP templates.

🛡️ Audit Your SOPs Against All 1,620 Clauses →
All Programs (40)Bioresearch MonitoringCosmetics (MoCRA)DevicesDietary SupplementsDrugsFoods
21 CFR 111.75(a)(1)(i) Dietary Supplements
Rank #1 · 318 Annual FDA Citations
21 CFR 111.75(a)(1)(i): Failure to conduct at least one test or examination to verify ingredient identity

Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.

Official Inspector Observation Language: "Your firm failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to use in manufacturing a dietary suppleme..."
Theme: Incoming Ingredient Identity Testing & COA Qualification
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21 CFR 111.75(a)(2)(ii) Dietary Supplements
Rank #2 · 284 Annual FDA Citations
21 CFR 111.75(a)(2)(ii): Reliance on supplier Certificate of Analysis (COA) without qualifying the supplier

Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.

Official Inspector Observation Language: "Your firm relied on a certificate of analysis from a component supplier to confirm the identity of components without first establishing the reliability of the supplier's certificate of anal..."
Theme: Incoming Ingredient Identity Testing & COA Qualification
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21 CFR 111.205(a) Dietary Supplements
Rank #3 · 261 Annual FDA Citations
21 CFR 111.205(a): Failure to prepare and follow a written Master Manufacturing Record (MMR)

Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.

Official Inspector Observation Language: "Your firm failed to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure unifor..."
Theme: Master Manufacturing & Batch Production Records (MMR/BPR)
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21 CFR 111.260(e) Dietary Supplements
Rank #4 · 239 Annual FDA Citations
21 CFR 111.260(e): Incomplete Batch Production Record (BPR) — missing component weights and lot numbers

Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.

Official Inspector Observation Language: "Your batch production records failed to include complete information relating to the production and control of each batch, including the identity and weight or measure of each component used..."
Theme: Master Manufacturing & Batch Production Records (MMR/BPR)
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21 CFR 111.75(c) Dietary Supplements
Rank #5 · 227 Annual FDA Citations
21 CFR 111.75(c): Failure to verify finished dietary supplement batch meets product specifications

Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.

Official Inspector Observation Language: "Your firm failed to verify, for a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan, or for every finished batch, that your finished b..."
Theme: Finished Product Testing, Stability & Expiration Dating
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