FDA Inspection 1286008 — HIKMA PHARMACEUTICALS USA INC.
The FDA completed an inspection of HIKMA PHARMACEUTICALS USA INC. on Jul 13, 2026 in Berkeley Heights, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- Jul 13, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Berkeley Heights, NJ (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |