21 CFR 211.115
Reprocessing
21 CFR 211.115 is the regulation titled “Reprocessing” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 1 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 200.10, in 1 letter
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
It is a drug letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 02025
- 12026
What FDA writes when it cites it
The finding headings that cite 21 CFR 211.115 most often, as written in the letters.
- 1 letterYour firm failed to establish and follow written procedures prescribing a system for reprocessing batches that do not conform to standards or specifications and the steps to be taken to ensure that the reprocessed…
- 1 letterYour firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product…
The regulation
Read the text of 21 CFR 211.115 (eCFR, as of Sep 1, 2026)
(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.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.115.
- 21 CFR 200.10Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers1 letter cites both
- 21 CFR 201.115New drugs or new animal drugs1 letter cites both
- 21 CFR 210.1Status of current good manufacturing practice regulations1 letter cites both
- 21 CFR 211.100Written procedures; deviations1 letter cites both
- 21 CFR 211.113Control of microbiological contamination1 letter cites both
- 21 CFR 211.125Labeling issuance1 letter cites both
- 21 CFR 211.160General requirements1 letter cites both
- 21 CFR 211.188Batch production and control records1 letter cites both
Latest letters citing it
The letter citing 21 CFR 211.115 that FDA posted most recently.
See the letter citing 21 CFR 211.115 →Put this kind of reading to
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Counts include every citation in a letter, as the Letters filter does. How this database is built.