FDA Inspection
Cosette Pharmaceuticals, Inc.Cosette Pharmaceuticals, Inc. – FDA Inspection, Jun 18, 2009
Record Details
This FDA Inspection record concerns Cosette Pharmaceuticals, Inc., with an inspection on June 18, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 18, 2009
- Product Type
- Drugs
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ID · c39122cd-d627-4b06-819b-e69e4a72e33a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 590096
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
15- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.134(a)Correct labels during finishing operations
- 21 CFR 211.28(a)Protective Apparel Not Worn
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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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