21 CFR 211.113
Control of microbiological contamination
21 CFR 211.113 is the regulation titled “Control of microbiological contamination” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 115 FDA warning letters have cited it.
- Letters citing it
- 115 since 2021
- Jan 1 to Oct 30, 2026
- 32 against 21 on the same dates in 2025
- Most often cited with
- 21 CFR 211.42, in 73 letters
- Closed out
- 10% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (93 of 115). 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 211.113 most often, as written in the letters.
- 52 lettersYour firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic…
- 5 lettersFailure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and…
- 5 lettersYour firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and…
The regulation
Read the text of 21 CFR 211.113 (eCFR, as of Sep 1, 2026)
(a) Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile, shall be established and followed.
(b) Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, shall be established and followed. Such procedures shall include validation of all aseptic and sterilization processes.
[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.113.
- 21 CFR 211.42Design and construction features73 letters cite both
- 21 CFR 211.192Production record review67 letters cite both
- 21 CFR 211.100Written procedures; deviations46 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit35 letters cite both
- 21 CFR 211.160General requirements33 letters cite both
- 21 CFR 211.166Stability testing33 letters cite both
- 21 CFR 200.10Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers29 letters cite both
- 21 CFR 210.1Status of current good manufacturing practice regulations29 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 211.113 that FDA posted most recently.
- DrugsView Rohto Pharmaceutical Co., Ltd.Over-the-counter topical ophthalmic drug products manufactured using aseptic processing.IssuedOct 14, 2026PostedOct 20, 2026
- DrugsView Baxter International Inc.Sterile injectable drugs, including cephalosporins and other productsIssuedSep 29, 2026PostedOct 20, 2026
- DrugsView Hanlim Pharm Co., Ltd.sterile (b)(4) drug productsIssuedOct 2, 2026PostedOct 13, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.