21 CFR 111.610
§ 111.610 What records must be made available to FDA?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 111.610, § 111.610 What records must be made available to FDA?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/84222
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Full text
(a) You must have all records required under this part, or copies of such records, readily available during the retention period for inspection and copying by FDA when requested.
(b) If you use reduction techniques, such as microfilming, you must make suitable reader and photocopying equipment readily available to FDA.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.