FDA Inspection
Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc. – FDA Inspection, Apr 13, 2011
Record Details
This FDA Inspection record concerns Hikma Pharmaceuticals USA Inc., with an inspection on April 13, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 13, 2011
- Product Type
- Drugs
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ID · 3b1bc6a2-8ac1-4b60-a098-8379bc7ac530
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 719344
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.134(a)Correct labels during finishing operations
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Other FDA inspections of Hikma Pharmaceuticals USA Inc.
18| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2026 | Not classified | New Jersey District Office | |
| June 12, 2024 | VAI | Drug Quality Assurance | |
| November 3, 2023 | VAI | Drug Quality Assurance | |
| July 7, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 10, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hikma Pharmaceuticals USA Inc.
- FDA Inspection 1304368 - 2026-05-13
- FDA Inspection 1237333 - 2024-06-12
- FDA Inspection 1222115 - 2023-11-03
- FDA Inspection 1176451 - 2022-07-07
- FDA Inspection 1106822 - 2019-09-10
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