FDA Inspection 1034742 — Athenex Pharma Solutions, LLC
The FDA completed an inspection of Athenex Pharma Solutions, LLC on Dec 13, 2017 in Clarence, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 13, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Clarence, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 18008 | FDCA 503B(a)(10) | Drug product label, outsourcer facility |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |