21 CFR 822.37
§ 822.37 Under what circumstances would you inspect records identifying subjects?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 822.37, § 822.37 Under what circumstances would you inspect records identifying subjects?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88962
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Full text
We can inspect and copy records identifying subjects under the same circumstances that we can inspect any records relating to postmarket surveillance. We are likely to be interested in such records if we have reason to believe that required reports have not been submitted, or are incomplete, inaccurate, false, or misleading.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.