FDA Inspection 545688 — PCI Inc
The FDA completed an inspection of PCI Inc on October 21, 2008 in Olivette, MO. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 21, 2008
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Olivette, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |