FDA Inspection
Cosette Pharmaceuticals NC Laboratories, LLCCosette Pharmaceuticals NC Laboratories, LLC – FDA Inspection, Jul 21, 2023
Record Details
This FDA Inspection record concerns Cosette Pharmaceuticals NC Laboratories, LLC, with an inspection on July 21, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 1761030b-2801-4690-9cac-346d121848c1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210546
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.42(c)(1)Incoming material area
- 21 CFR 211.80(a)Written Procedures Not Followed
- 21 CFR 211.42(c)(1)Incoming material area
- 21 CFR 211.80(a)Written Procedures Not Followed
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Other FDA inspections of Cosette Pharmaceuticals NC Laboratories, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 30, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 29, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 24, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 25, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 4, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cosette Pharmaceuticals NC Laboratories, LLC
- FDA Inspection 1035767 - 2017-11-30
- FDA Inspection 983395 - 2016-07-29
- FDA Inspection 870025 - 2014-02-24
- FDA Inspection 801611 - 2012-09-25
- FDA Inspection 713187 - 2011-03-04
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