FDA Inspection 981353 — Hikma Pharmaceuticals LLC
The FDA completed an inspection of Hikma Pharmaceuticals LLC on Jul 27, 2016 in Amman. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 27, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Amman (Jordan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |