FDA Inspection
Hikma Pharmaceuticals USA INC.Hikma Pharmaceuticals USA INC. – FDA Inspection, Apr 18, 2018
Record Details
This FDA Inspection record concerns Hikma Pharmaceuticals USA INC., with an inspection on April 18, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f653373d-636c-49f3-be34-0e917a8401b3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049821
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Hikma Pharmaceuticals USA INC.
27| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2026 | Not classified | Cincinnati District Office | |
| April 30, 2026 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 17, 2025 | Not classified | Cincinnati District Office | |
| July 23, 2024 | NAI | Compliance: Devices | |
| September 15, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hikma Pharmaceuticals USA INC.
- FDA Inspection 1285748 - 2026-09-18
- FDA Inspection 1303412 - 2026-04-30
- FDA Inspection 1238509 - 2025-01-17
- FDA Inspection 1243797 - 2024-07-23
- FDA Inspection 1182363 - 2022-09-15
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