21 CFR Part 211 · Current Good Manufacturing Practice for Finished Pharmaceuticals
(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.
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Form FDA 483 observations citing this section, fiscal years 2009–2026 (Drugs).
203 FDA warning letters since 2017 cite this section ; the most recent:
Federal Register documents that created or amended this section.