21 CFR 211.87
Retesting of approved components, drug product containers, and closures
21 CFR 211.87 is the regulation titled “Retesting of approved components, drug product containers, and closures” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 2 FDA warning letters have cited it.
- Letters citing it
- 2 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 211.100, in 2 letters
- Closed out
- 50% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 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 211.87 most often, as written in the letters.
- 1 letterYour firm failed to prepare batch production and control records for each batch of drug product that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or…
- 1 letterYour firm failed to retest or reexamine components, as appropriate, for identity, strength, quality, and purity and your quality control unit failed to approve or reject components (21 CFR 211.87)
The regulation
Read the text of 21 CFR 211.87 (eCFR, as of Sep 1, 2026)
Components, drug product containers, and closures shall be retested or reexamined, as appropriate, for identity, strength, quality, and purity and approved or rejected by the quality control unit in accordance with § 211.84 as necessary, e.g., after storage for long periods or after exposure to air, heat or other conditions that might adversely affect the component, drug product container, or closure.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.87.
- 21 CFR 211.100Written procedures; deviations2 letters cite both
- 21 CFR 200.10Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers1 letter cites both
- 21 CFR 201.115New drugs or new animal drugs1 letter cites both
- 21 CFR 201.128Meaning of “intended uses”1 letter cites both
- 21 CFR 210.1Status of current good manufacturing practice regulations1 letter cites both
- 21 CFR 211.113Control of microbiological contamination1 letter cites both
- 21 CFR 211.137Expiration dating1 letter cites both
- 21 CFR 211.188Batch production and control records1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 211.87 that FDA posted most recently.
- DrugsView Cosco International, Inc.OTC drug products including topical wound treatments and antiperspirant lotionsIssuedApr 14, 2025PostedApr 29, 2025
- DrugsView Advanced Nutriceuticals, LLC dba The Guyer Institute of Molecular Medicinecompounded sterile drug productsIssuedNov 10, 2021PostedNov 16, 2021
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Counts include every citation in a letter, as the Letters filter does. How this database is built.