FDA Inspection
Aidarex Pharmaceuticals LLCAidarex Pharmaceuticals LLC – FDA Inspection, Feb 22, 2012
Record Details
This FDA Inspection record concerns Aidarex Pharmaceuticals LLC, with an inspection on February 22, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aidarex Pharmaceuticals LLC
- Inspection Date
- February 22, 2012
- Product Type
- Drugs
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ID · b80a4060-0ce6-4b08-bc62-f08e3e102769
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 771045
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.176Failing to test for penicillin cross-contamination
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Aidarex Pharmaceuticals LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 20, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 6, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Aidarex Pharmaceuticals LLC
- FDA Inspection 1029306 - 2017-10-20
- FDA Inspection 983014 - 2016-06-06
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