FDA Access to Corrections and Removals Records: §806.30

Maps to

21 CFR Part 806: §806.30 FDA access to records.

Requirement text

Every device manufacturer or importer required to maintain corrections and removals records, and every person in charge or custody of such records, must permit, upon request of an authorized FDA officer or employee, access to, and the right to copy and verify, those records and reports at all reasonable times.

21 CFR § 806.30 — current eCFR →

Related clauses

MDR Reporting Requirements — General Obligations Written MDR Procedures MDR Event Files and Records Retention Manufacturer MDR Reporting — Adverse Event Investigation and Submission 5-Day Expedited MDR Reports Reports of Corrections and Removals

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21 CFR Part 806 §806.30

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Requirement text

Related clauses

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