FDA Inspection
Hikma Pharmaceuticals USA, Inc.Hikma Pharmaceuticals USA, Inc. – FDA Inspection, Mar 25, 2011
Record Details
This FDA Inspection record concerns Hikma Pharmaceuticals USA, Inc., with an inspection on March 25, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 25, 2011
- Product Type
- Drugs
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ID · 1064a8bf-87bb-4945-b0ab-b8c7652576ba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 715967
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 314.80(b)Failure to review ADE information
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Other FDA inspections of Hikma Pharmaceuticals USA, Inc.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| April 13, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 7, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 10, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 26, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hikma Pharmaceuticals USA, Inc.
- FDA Inspection 1079961 - 2019-02-01
- FDA Inspection 1054739 - 2018-04-13
- FDA Inspection 976090 - 2016-07-07
- FDA Inspection 942928 - 2015-09-10
- FDA Inspection 864847 - 2014-02-26
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