667579
Medical Products Laboratories, Inc. — FEI 2513595
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 14, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 4309 | 21 CFR 211.84(c)(2) | Containers sampled so as to prevent contamination |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |