Each device manufacturer or importer required under this part to maintain records and every person who is in charge or custody of such records shall, upon request of an officer or employee designated by FDA and under section 704(e) of the act, permit such officer or employee at all reasonable times to have access to, and to copy and verify, such records and reports.
21 CFR Part 806 · Medical Devices; Reports of Corrections and Removals
§ 806.30 FDA access to records
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 806.30
Form FDA 483 observations citing this section, fiscal years 2010–2012 (Devices).
- Access not permitted 3
Amendment history
Federal Register documents that created or amended this section.
- 63 FR 42233 7 Aug 1998