FDA Inspection
Hikma Injectables USA IncHikma Injectables USA Inc – FDA Inspection, Jun 8, 2022
Record Details
This FDA Inspection record concerns Hikma Injectables USA Inc, with an inspection on June 8, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Hikma Injectables USA Inc
- Inspection Date
- June 8, 2022
- Product Type
- Drugs
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ID · 52afa7fb-d01b-4c13-8b57-fd998b42151e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1171399
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
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Other FDA inspections of Hikma Injectables USA Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2025 | Not classified | New Jersey District Office | Drug Quality Assurance |
| June 25, 2024 | Not classified | New Jersey District Office | Drug Quality Assurance |
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