21 CFR 211.115: Reprocessing
Requires manufacturers to establish and follow written procedures for reprocessing nonconforming batches so they meet all standards and specifications, and prohibits any reprocessing without prior review and approval by the quality control unit.
Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals · Subpart F, Production and Process Controls
How FDA words it
The opening lines investigators use most when they cite 211.115, from the 483s we hold.
Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are not written.Most used
Reprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with all established standards, specifications, and characteristics.211.115(a)
Cited over time
483s citing 211.115, 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 211.115
- GenoGeni x · Boca Raton, FloridaReprocessing procedures lack the steps to be taken to ensure that reprocessed… Jul 18, 2025
- Nitro Quimica Corporation dba Alchemix A Nitro Quimica Corporation · College Park, GeorgiaProcedures prescribing a system for reprocessing batches to insure that the… Feb 21, 2025
- Prime Enterprises, LLC dba Prime Matter Labs · Miami, FloridaReprocessing was performed without the review and approval of the quality control… Sep 1, 2023
- ABC Compounding Co., Inc. · Conyers, GeorgiaReprocessing procedures lack the steps to be taken to insure that reprocessed… Apr 21, 2023
- Dextrum Laboratories Inc · Miami, FloridaProcedures prescribing a system for reprocessing batches to insure that the… Dec 16, 2022
The regulation text
§ 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.
Questions
What does 21 CFR 211.115 require?
Requires manufacturers to establish and follow written procedures for reprocessing nonconforming batches so they meet all standards and specifications, and prohibits any reprocessing without prior review and approval by the quality control unit.
How do FDA investigators word a 211.115 observation?
The most common opening is: “Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are not written.”
Which sections are cited alongside 211.115?
In the same 483s, investigators most often also cite 211.192 (Production record review), 211.160 (General requirements), 211.165 (Testing and release for distribution), 211.22 (Responsibilities of quality control unit).