FDA Inspection
Hikma Pharmaceuticals LLCHikma Pharmaceuticals LLC – FDA Inspection, Jun 25, 2015
Record Details
This FDA Inspection record concerns Hikma Pharmaceuticals LLC, with an inspection on June 25, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Hikma Pharmaceuticals LLC
- Inspection Date
- June 25, 2015
- Product Type
- Drugs
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ID · 2436b6f5-092b-4dc1-9987-642fa6215ad7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 935111
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.165(e)Test methods
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Other FDA inspections of Hikma Pharmaceuticals LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 27, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 12, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 4, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hikma Pharmaceuticals LLC
- FDA Inspection 1101407 - 2019-09-05
- FDA Inspection 981353 - 2016-07-27
- FDA Inspection 782232 - 2012-04-12
- FDA Inspection 645014 - 2010-02-04
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