21 CFR 600.21
§ 600.21 Time of inspection.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 600.21, § 600.21 Time of inspection, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88305
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Full text
The inspection of an establishment for which a biologics license application is pending need not be made until the establishment is in operation and is manufacturing the complete product for which a biologics license is desired.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.