FDA Inspection
Cosette Pharmaceuticals, Inc.Cosette Pharmaceuticals, Inc. – FDA Inspection, May 17, 2010
Record Details
This FDA Inspection record concerns Cosette Pharmaceuticals, Inc., with an inspection on May 17, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 17, 2010
- Product Type
- Drugs
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ID · 1ccb996d-126c-4b46-ab1a-ead8bd1dcc5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 662123
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.192No written record of investigation
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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 |
| February 15, 2018 | VAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
| January 26, 2017 | NAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
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 1041164 - 2018-02-15
- FDA Inspection 1009132 - 2017-01-26
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