21 CFR 111.103
§ 111.103 What are the requirements under this subpart F for written procedures?
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 111.103, § 111.103 What are the requirements under this subpart F for written procedures?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84157
- Permanent ID
ys:prov:84157@1- SHA-256
94126a6cdce7ce8279db24124cf751a4a83fc273e1e2084ee969d0cdcd5248cc
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
You must establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.