§ 211.115 Reprocessing

(a) Written procedures shall be established and followed prescribing a system for reprocessing batches that do not conform to standards or specifications and the steps to be taken to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics.

(b) Reprocessing shall not be performed without the review and approval of the quality control unit.

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What FDA inspectors cite under § 211.115

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Drugs).

• Reprocessing procedures not written or followed 61
• Reprocessing procedures lack steps to be taken 24
• Reprocessing/quality control unit 15

Warning letters citing § 211.115

1 FDA warning letters since 2017 cite this section :

• GenoGenix LLC 20 Jan 2026

FDA guidance that cites § 211.115

• Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry 28 Jan 2020
• ANDA Submissions — Content and Format of Abbreviated New Drug Applications: Guidance for Industry 20 Jun 2019
• CPG Sec. 490.200 Parametric Release of Parenteral Drug Products Terminally Sterilized by Moist Heat 1 Jul 2012
• Cooperative Manufacturing Arrangements for Licensed Biologics: Guidance for Industry 28 Nov 2008
• Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations 2 Oct 2006

Amendment history

Federal Register documents that created or amended this section.

• 43 FR 45077 29 Sept 1978