REGI US INC
FDA inspection history in West Caldwell, New Jersey, 2019 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at West Caldwell, New Jersey.
- 2025One Form 483, at West Caldwell, New Jersey.
- 2025The longest 483 on file: 4 observations over 5 pages at West Caldwell, New Jersey.
Cited most
Across all REGI US observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.180(e)General requirements1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures1
The complete REGI US file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
West Caldwell, New Jersey
Two Form 483s · 2019 to 2025 · 5 observations
Latest: Form 483, Jan 22, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-01-22 | 483 Form 483 | West Caldwell, New Jersey | 4 | $99 |
| 2019-01-15 | 483 Form 483 | West Caldwell, New Jersey | 1 | $99 |
Investigators on these documents
Emmanuel J. Ramos Maldonado (1)Jenny Sung (1)Victoria Spivak (1)
FEI number 3012525449 · most recent document Jan 22, 2025
About REGI US INC
How many FDA Form 483s has REGI US INC received?
FDA Intel has 2 Form 483s on file for REGI US INC; the most recent is dated Jan 22, 2025.
When was REGI US INC last inspected by FDA?
The most recent FDA inspection document on file for REGI US INC is a Form 483 dated Jan 22, 2025, for the site in West Caldwell, New Jersey.
What did FDA cite at REGI US INC?
The regulations cited most in the observations on file for REGI US INC are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.180(e) (General requirements), 1 time; 21 CFR 211.188 (Batch production and control records), 1 time.