21 CFR 211.115

§ 211.115 Reprocessing.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 211.115, § 211.115 Reprocessing, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/85969
Permanent ID: ys:prov:85969@1
SHA-256: 1d034b66c4c48f6f2e6c2f812beaab7073482d9fd583c070f007b506fc023933

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Full text

(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.