Company
United StatesCosette Pharmaceuticals, Inc., South Plainfield, NJ – FDA Inspections
Inspection records and compliance data for Cosette Pharmaceuticals, Inc. in South Plainfield, New Jersey. 10 FDA inspections on record (1 OAI), 2 Form 483s, last inspected November 15, 2024.
Company Profile
This profile covers Cosette Pharmaceuticals, Inc. based in South Plainfield, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 1
- VAI
- 2
- NAI
- 6
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected June 18, 2009. Last inspected November 15, 2024.
Most cited issue areas
- Procedures not in writing, fully followed3 inspections
- Approve or reject components, products2 inspections
- Authority lacking to review records, investigate errors2 inspections
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 15, 2024 | Not classified | Human Drugs | 1264195 |
| January 25, 2024 | NAI | Human Drugs · Bioresearch Monitoring | 1230559 |
| March 29, 2018 | NAI | Human Drugs · Bioresearch Monitoring | 1047980 |
| February 15, 2018 | VAI | Human Drugs · Generic Drug Evaluation | 1041164 |
| January 26, 2017 | NAI | Human Drugs · Generic Drug Evaluation | 1009132 |
| November 19, 2013 | NAI | Human Drugs · Drug Quality Assurance | 854338 |
| January 12, 2012 | NAI | Human Drugs · Bioresearch Monitoring | 762705 |
| April 15, 2011 | NAI | Human Drugs · Drug Quality Assurance | 720565 |
| May 17, 2010 | VAI | Human Drugs · Drug Quality Assurance | 662123 |
| June 18, 2009 | OAI | Human Drugs · Drug Quality Assurance | 590096 |
FDA documents
Form 483s (1)
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Company Information
Name
Cosette Pharmaceuticals, Inc.
FEI Number
2210277
Address
101 Coolidge St, South Plainfield, New Jersey 07080, United States
Country
United States
ID: 8c3e01d0-f022-4434-8a43-729e36808be4