Company
United StatesREGI US INC - Inspection Records
Inspection records and compliance data for REGI US INC in West Caldwell, New Jersey. 2 FDA inspections on record, 1 Form 483, last inspected January 22, 2025.
Company Profile
This profile covers REGI US INC based in West Caldwell, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected January 15, 2019. Last inspected January 22, 2025.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Establish reliability of supplier's C of A1 inspection
- Establish reliability of supplier"s C of A1 inspection
Most recent inspections
| Date | Classification | Office | Project area |
|---|---|---|---|
| January 22, 2025 | VAI | New Jersey District Office | Drug Quality Assurance |
| January 15, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Documents (3)
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Name
REGI US INC
FEI Number
3012525449
State
New Jersey
City
West Caldwell
ID: 0596d9b3-58c6-48ab-89fb-096ab585b2dd