1014140
Exeltis USA, Inc. — FEI 3008163531
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 6, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Florham Park, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15983 | 21 CFR 111.123(a)(7) | Quality control operations - finished batch, specifications |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2621 | 21 CFR 211.198(b)(3) | Reason for Not Conducting Complaint Investigation |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |