REGI US INC
Form 483 issued January 22, 2025 · West Caldwell, New Jersey
- Inspection
- Jan 14 – Jan 22, 2025
- Investigators
- Jenny Sung· Victoria Spivak
- Observations
- 4
- Pages
- 5
- FEI number
- 3012525449
In short: On January 22, 2025, FDA issued a Form 483 with 4 observations to REGI US INC in West Caldwell, New Jersey (FEI 3012525449) after an inspection that ran Jan 14 – Jan 22, 2025. The investigators were Jenny Sung and Victoria Spivak. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Jenny Sung
4 documents · 2004–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmREGI US INC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at REGI US INC?
FDA listed 4 observations on this Form 483, mostly about quality system, production and materials. The opening words of each observation are shown on this page.
Who inspected REGI US INC?
Jenny Sung and Victoria Spivak are named on this Form 483, for the inspection of Jan 14 – Jan 22, 2025. Each investigator has a profile showing what they cite most.
When was REGI US INC inspected by FDA?
The inspection ran Jan 14 – Jan 22, 2025, and the Form 483 is dated January 22, 2025.
How do I get the full Form 483 for REGI US INC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.