CFR section
21 CFR 806.30: FDA access to records
PART 806-MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS · Subpart B-Reports and Records
Key facts
| Citation | 21 CFR 806.30 |
|---|---|
| Section | FDA access to records |
| Part | PART 806-MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS |
| Subpart | Subpart B-Reports and Records |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs |
| Regulation text (excerpt) | 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. |
At a glance
- 1–9 Inspections citing this section
- 1–9 Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.