682729
Marlex Pharmaceuticals, Inc. — FEI 1000121454
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 5, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- New Castle, DE (United States)
Citations
| ID | CFR | Description |
|---|
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1797 | 21 CFR 211.82(a) | Examination on receipt, before acceptance |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3545 | 21 CFR 211.44 | Adequate lighting not provided |
| 3548 | 21 CFR 211.46(c) | Air filtration system lacking in production area |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |