FDA Inspection 935401 — Medical Products Laboratories, Inc.
The FDA completed an inspection of Medical Products Laboratories, Inc. on July 21, 2015 in Philadelphia, 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
- July 21, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |