FDA Inspection 1026858 — Exela Pharma Sciences LLC
The FDA completed an inspection of Exela Pharma Sciences LLC on September 28, 2017 in Lenoir, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 28, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lenoir, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1725 | 21 CFR 211.134(c) | Examinations documented |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 18008 | FDCA 503B(a)(10) | Drug product label, outsourcer facility |