21 CFR 211.115 - Reprocessing.
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(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.
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.