FDA Inspection 592108 — University Of Pittsburgh Medical Center Centralized Packaging
The FDA completed an inspection of University Of Pittsburgh Medical Center Centralized Packaging on June 5, 2009 in Pittsburgh, PA. 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
- June 5, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pittsburgh, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |