FDA Inspection 1180929 — Akan Biosciences Inc
The FDA completed an inspection of Akan Biosciences Inc on Sep 30, 2022 in Gaithersburg, MD. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 30, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Gaithersburg, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12257 | 21 CFR 1271.60(c)(2) | Records stating determination not completed |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |
| 12312 | 21 CFR 1271.160(b)(2) | Procedures for complaints and other information |
| 12329 | 21 CFR 1271.160(d) | Documentation/approval prior to implementation |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12423 | 21 CFR 1271.265(b) | Shipment in quarantine of HCT/Ps |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |