FDA Inspection 1208142 — AmerisourceBergen Drug Corp.
The FDA completed an inspection of AmerisourceBergen Drug Corp. on June 15, 2023 in Morrisville, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 15, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Morrisville, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 16000 | 21 CFR 111.130 | Quality control operations - returned dietary supplement |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |