21 CFR 821.50
§ 821.50 Availability.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 821.50, § 821.50 Availability, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88915
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Full text
(a) Manufacturers, distributors, multiple distributors, and final distributors shall, upon the presentation by an FDA representative of official credentials and the issuance of Form FDA 482 at the initiation of an inspection of an establishment or person under section 704 of the act, make each record and all information required to be collected and maintained under this part and all records and information related to the events and persons identified in such records available to FDA personnel.
(b) Records and information referenced in paragraph (a) of this section shall be available to FDA personnel for purposes of reviewing, copying, or any other use related to the enforcement of the act and this part. Records required to be kept by this part shall be kept in a centralized point for each manufacturer or distributor within the United States.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.