FDA Inspection
Quadex Pharmaceuticals, LlcQuadex Pharmaceuticals, Llc – FDA Inspection, Jun 28, 2011
Record Details
This FDA Inspection record concerns Quadex Pharmaceuticals, Llc, with an inspection on June 28, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Quadex Pharmaceuticals, Llc
- Inspection Date
- June 28, 2011
- Product Type
- Drugs
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ID · 7b0e0c3a-d628-4793-8d57-43db300cc47b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 732115
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.204Record information inclusions
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Quadex Pharmaceuticals, Llc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 25, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Quadex Pharmaceuticals, Llc
- FDA Inspection 867670 - 2014-02-25
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