FDA Inspection
Cosette Pharmaceuticals, Inc.Cosette Pharmaceuticals, Inc. – FDA Inspection, Jan 26, 2017
Record Details
This FDA Inspection record concerns Cosette Pharmaceuticals, Inc., with an inspection on January 26, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · dccd07c1-f9ef-438a-a080-47034bea2c19
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1009132
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| 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 1041164 - 2018-02-15
- FDA Inspection 854338 - 2013-11-19
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