21 CFR 211.165
Testing and release for distribution
21 CFR 211.165 is the regulation titled “Testing and release for distribution” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 202 FDA warning letters have cited it.
- Letters citing it
- 202 since 2021
- Jan 1 to Oct 30, 2026
- 28 against 32 on the same dates in 2025
- Most often cited with
- 21 CFR 211.84, in 142 letters
- Closed out
- 2% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (196 of 202). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 211.165 most often, as written in the letters.
- 74 lettersYour firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active…
- 13 lettersYour firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b))
- 11 lettersYour firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e))
The regulation
Read the text of 21 CFR 211.165 (eCFR, as of Sep 1, 2026)
(a) For each batch of drug product, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Where sterility and/or pyrogen testing are conducted on specific batches of shortlived radiopharmaceuticals, such batches may be released prior to completion of sterility and/or pyrogen testing, provided such testing is completed as soon as possible.
(b) There shall be appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms.
(c) Any sampling and testing plans shall be described in written procedures that shall include the method of sampling and the number of units per batch to be tested; such written procedure shall be followed.
(d) Acceptance criteria for the sampling and testing conducted by the quality control unit shall be adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release. The statistical quality control criteria shall include appropriate acceptance levels and/or appropriate rejection levels.
(e) The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented. Such validation and documentation may be accomplished in accordance with § 211.194(a)(2).
(f) Drug products failing to meet established standards or specifications and any other relevant quality control criteria shall be rejected. Reprocessing may be performed. Prior to acceptance and use, reprocessed material must meet appropriate standards, specifications, and any other relevant criteria.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.165.
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures142 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit108 letters cite both
- 21 CFR 211.100Written procedures; deviations104 letters cite both
- 21 CFR 211.166Stability testing89 letters cite both
- 21 CFR 211.192Production record review51 letters cite both
- 21 CFR 201.128Meaning of “intended uses”49 letters cite both
- 21 CFR 211.188Batch production and control records41 letters cite both
- 21 CFR 211.67Equipment cleaning and maintenance41 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.165 that FDA posted most recently.
- DrugsView Conroe Welding Supply, Inc.Oxygen, USP for administration by inhalationIssuedOct 29, 2026PostedNov 3, 2026
- DrugsView Guangdong Bangze Medicine Co., Ltd.OTC drug productsIssuedOct 26, 2026PostedNov 3, 2026
- DrugsView TSP Solutions Pte. Ltd.OTC sunscreen drug productsIssuedOct 22, 2026PostedOct 27, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.