Company
United StatesChartwell Pharmaceuticals West Caldwell LLC, West Caldwell, NJ – FDA Inspections
Inspection records and compliance data for Chartwell Pharmaceuticals West Caldwell LLC in West Caldwell, New Jersey. 5 FDA inspections on record, 1 Form 483, last inspected December 18, 2024.
Company Profile
This profile covers Chartwell Pharmaceuticals West Caldwell LLC based in West Caldwell, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected September 7, 2011. Last inspected December 18, 2024.
Most cited issue areas
- Calibration - at intervals, written program, remedial action1 inspection
- Calibration/Inspection/Checking not done1 inspection
- Failure to develop written procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 18, 2024 | VAI | Human Drugs · Generic Drug Evaluation | 1257037 |
| September 18, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1030229 |
| May 25, 2016 | VAI | Human Drugs · Bioresearch Monitoring | 973194 |
| September 6, 2013 | NAI | Human Drugs · Drug Quality Assurance | 847035 |
| September 7, 2011 | VAI | Human Drugs · Drug Quality Assurance | 740705 |
FDA documents
Form 483s (1)
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Company Information
Name
Chartwell Pharmaceuticals West Caldwell LLC
FEI Number
3005376609
Address
200 Fairfield Ave, West Caldwell, New Jersey 07006, United States
Country
United States
ID: b2b85c90-5235-447f-a2ce-36cf51c7d0f1