FDA Inspection
Hikma Pharmaceuticals LLCHikma Pharmaceuticals LLC – FDA Inspection, Sep 5, 2019
Record Details
This FDA Inspection record concerns Hikma Pharmaceuticals LLC, with an inspection on September 5, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 6277d74f-baf0-459a-967a-660b10579d63
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101407
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Hikma Pharmaceuticals LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 27, 2016 | 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 981353 - 2016-07-27
- FDA Inspection 935111 - 2015-06-25
- FDA Inspection 782232 - 2012-04-12
- FDA Inspection 645014 - 2010-02-04
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