FDA Inspection
Hikma Pharmaceuticals LLCHikma Pharmaceuticals LLC – FDA Inspection, Jul 27, 2016
Record Details
This FDA Inspection record concerns Hikma Pharmaceuticals LLC, with an inspection on July 27, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Hikma Pharmaceuticals LLC
- Inspection Date
- July 27, 2016
- Product Type
- Drugs
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ID · 193e7e0e-6255-409e-9810-4a1543d27a9d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 981353
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.67(b)Written procedures not established/followed
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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 |
| June 25, 2015 | 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 935111 - 2015-06-25
- FDA Inspection 782232 - 2012-04-12
- FDA Inspection 645014 - 2010-02-04
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