21 CFR 211.113: Control of microbiological contamination
Requires manufacturers to establish and follow written procedures preventing objectionable microorganisms in non-sterile drugs and microbial contamination of sterile drugs, including validation of all aseptic and sterilization processes.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart F, Production and Process Controls
28%
of drug-manufacturing 483s since 2023 cite this section at least once
How FDA words it
The opening lines investigators use most when they cite 211.113, from the 483s we hold.
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.Most used
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.211.113(a)
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.
Cited over time
483s citing 211.113, by yearMost citations in 2019. Bars are relative to the busiest year. *2026 to date.
Years shown: 2017 to 2026. The busiest year was 2019.
Recent 483s citing 211.113
- Victory Medical Center Pharmacy · Austin, TexasPersonnel were observed manually contacting the inner surface of a sterile… Sep 10, 2026
- Greenwich Rx · Tomball, TexasMicrobial contamination was present in the ISO 5 area and areas adjacent to… Sep 9, 2026
- Right Value Drug Stores LLC · Irving, TexasProcedures designed to prevent microbiological contamination of drug products… Sep 8, 2026
- RC Outsourcing, LLC · Lowellville, OhioProcedures designed to prevent microbiological contamination of drug products… Sep 3, 2026
- OPS International Inc. dba Olympia Pharmaceuticals · Orlando, FloridaProcedures designed to prevent microbiological contamination of drug products… Sep 3, 2026
The regulation text
§ 211.113 Control of microbiological contamination.
(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]
Questions
What does 21 CFR 211.113 require?
Requires manufacturers to establish and follow written procedures preventing objectionable microorganisms in non-sterile drugs and microbial contamination of sterile drugs, including validation of all aseptic and sterilization processes.
How often is 211.113 cited in Form 483s?
It appears in about 28% of the drug-manufacturing 483s we hold from 2023 onward, which makes it one of the five most-cited sections in those 483s.
How do FDA investigators word a 211.113 observation?
The most common opening is: “Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.”
Which sections are cited alongside 211.113?
In the same 483s, investigators most often also cite 211.42 (Design and construction features), 211.192 (Production record review), 211.67 (Equipment cleaning and maintenance), 211.22 (Responsibilities of quality control unit).