Company
United StatesREGI US INC, West Caldwell, NJ – FDA Inspections
Inspection records and compliance data for REGI US INC in West Caldwell, New Jersey. 2 FDA inspections on record, 2 Form 483s, 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
- 2
- 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
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 22, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1260740 |
| January 15, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1076339 |
FDA documents
Form 483s (1)
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
REGI US INC
FEI Number
3012525449
Address
8 Fairfield Cres, West Caldwell, New Jersey 07006, United States
Country
United States
ID: 0596d9b3-58c6-48ab-89fb-096ab585b2dd