Company
United StatesQuagen Pharmaceuticals LLC, West Caldwell, NJ – FDA Inspections
Inspection records and compliance data for Quagen Pharmaceuticals LLC in West Caldwell, New Jersey. 4 FDA inspections on record, 1 Form 483, last inspected May 19, 2026.
Company Profile
This profile covers Quagen Pharmaceuticals LLC based in West Caldwell, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected March 15, 2019. Last inspected May 19, 2026.
Most cited issue areas
- Failure to develop written procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 19, 2026 | Not classified | Human Drugs | 1322648 |
| November 8, 2023 | VAI | Human Drugs · Bioresearch Monitoring | 1222389 |
| December 19, 2022 | NAI | Human Drugs · Drug Quality Assurance | 1194335 |
| March 15, 2019 | Not classified | Human Drugs | 1085743 |
FDA documents
Form 483s (1)
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Company Information
Name
Quagen Pharmaceuticals LLC
FEI Number
3012232287
Address
11 Patton Dr, West Caldwell, New Jersey 07006, United States
Country
United States
ID: 9f3a6bdf-7084-4753-aa36-3a336180eb8d