CFR section
21 CFR 821.50(a): Availability
PART 821-MEDICAL DEVICE TRACKING REQUIREMENTS · Subpart D-Records and Inspections
Key facts
| Citation | 21 CFR 821.50(a) |
|---|---|
| Section | Availability |
| Part | PART 821-MEDICAL DEVICE TRACKING REQUIREMENTS |
| Subpart | Subpart D-Records and Inspections |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (a) Manufacturers, distributors, multiple distributors, and final distributors shall, upon the presentation by an FDA representative of official credentials and the issuance of Form FDA 482 at the initiation of an inspection of an establishment or person under section 704 of the act, make each record and all information required to be collected and maintained under this part and all records and information related to the events and persons identified in such records available to FDA personnel. |
At a glance
- 1–9 Inspections citing this section
- None 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.