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Current as of January 02, 2025 | Updated by Findlaw Staff
(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.
Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.211.115 Reprocessing - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-211-115/
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