21 CFR 211.94
Drug product containers and closures
21 CFR 211.94 is the regulation titled “Drug product containers and closures” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 4 FDA warning letters have cited it.
- Letters citing it
- 4 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 211.113, in 4 letters
- Closed out
- 25% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (3 of 4). 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 211.94 most often, as written in the letters.
- 2 lettersYour firm failed to clean and sterilize and process, where indicated by the nature of the drug, container closures to remove pyrogenic properties to assure they are suitable for their intended use (21 CFR 211.94(c))
- 1 letterYour firm failed to ensure container closure systems provide protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product (21 CFR 211.94(b))
- 1 letterYour firm failed to ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a))
The regulation
Read the text of 21 CFR 211.94 (eCFR, as of Sep 1, 2026)
(a) Drug product containers and closures shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements.
(b) Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
(c) Drug product containers and closures shall be clean and, where indicated by the nature of the drug, sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use. Such depyrogenation processes shall be validated.
(d) Standards or specifications, methods of testing, and, where indicated, methods of cleaning, sterilizing, and processing to remove pyrogenic properties shall be written and followed for drug product containers and closures.
[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008; 81 FR 81697, Nov. 18, 2016; 89 FR 51769, June 18, 2024]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.94.
- 21 CFR 211.113Control of microbiological contamination4 letters cite both
- 21 CFR 200.10Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers3 letters cite both
- 21 CFR 210.1Status of current good manufacturing practice regulations3 letters cite both
- 21 CFR 211.42Design and construction features3 letters cite both
- 21 CFR 201.115New drugs or new animal drugs2 letters cite both
- 21 CFR 211.188Batch production and control records2 letters cite both
- 21 CFR 211.192Production record review2 letters cite both
- 21 CFR 211.67Equipment cleaning and maintenance2 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.94 that FDA posted most recently.
- DrugsView Right Value Drug Stores, LLC dba Carie Boyd PharmaceuticalsKetoconazole 2% Cream, Testosterone Cypionate 200 mg/ml injections, and Testosterone Cypionate 200 mg/ml + Testosterone Propionate 10 mg/mlIssuedDec 17, 2024PostedMar 11, 2025
- BiologicsView Regenerative Processing Plant, LLCRegener-Eyes PRO and LITE ophthalmic solutionsIssuedAug 16, 2024PostedSep 6, 2024
- DrugsView Sagent Pharmaceuticals, Inc.Sterile compounded drug products, including IV bagsIssuedJul 27, 2022PostedDec 20, 2022
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Counts include every citation in a letter, as the Letters filter does. How this database is built.