FDA Inspection
Cosette Pharmaceuticals, Inc.Cosette Pharmaceuticals, Inc. – FDA Inspection, Feb 15, 2018
Record Details
This FDA Inspection record concerns Cosette Pharmaceuticals, Inc., with an inspection on February 15, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e2de9ed1-1503-4872-847e-9fe73cd8a90d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1041164
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.84(c)(2)Containers sampled so as to prevent contamination
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Other FDA inspections of Cosette Pharmaceuticals, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2024 | Not classified | New Jersey District Office | |
| January 25, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| March 29, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 26, 2017 | NAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| November 19, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cosette Pharmaceuticals, Inc.
- FDA Inspection 1264195 - 2024-11-15
- FDA Inspection 1230559 - 2024-01-25
- FDA Inspection 1047980 - 2018-03-29
- FDA Inspection 1009132 - 2017-01-26
- FDA Inspection 854338 - 2013-11-19
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