FDA Inspection
Aidarex Pharmaceuticals LLCAidarex Pharmaceuticals LLC – FDA Inspection, Oct 20, 2017
Record Details
This FDA Inspection record concerns Aidarex Pharmaceuticals LLC, with an inspection on October 20, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a26c08bc-38a4-42d9-ade2-1807c3558ca3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029306
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
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Other FDA inspections of Aidarex Pharmaceuticals LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 22, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Aidarex Pharmaceuticals LLC
- FDA Inspection 983014 - 2016-06-06
- FDA Inspection 771045 - 2012-02-22
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