FDA Inspection 542388 — Amerisource Bergen Drug Corp
The FDA completed an inspection of Amerisource Bergen Drug Corp on October 7, 2008 in Des Moines, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 7, 2008
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Des Moines, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4415 | 21 CFR 211.204 | Returned drug products with doubt cast as to safety et. al. |