FDA Inspection 1014140 — Exeltis USA, Inc.
The FDA completed an inspection of Exeltis USA, Inc. on Jun 6, 2017 in Florham Park, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 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 |