REGI US INC
Form 483 issued January 15, 2019 · West Caldwell, New Jersey
- Inspection
- Jan 14 – Jan 15, 2019
- Investigator
- Emmanuel J. Ramos Maldonado
- Observations
- 1
- Pages
- 1
- FEI number
- 3012525449
In short: On January 15, 2019, FDA issued a Form 483 with 1 observation to REGI US INC in West Caldwell, New Jersey (FEI 3012525449) after an inspection that ran Jan 14 – Jan 15, 2019. The investigator was Emmanuel J. Ramos Maldonado. Most observations concern production; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.188 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The batch production and control records are deficient in that they do not include documentation of…
This inspection in context
Emmanuel J. Ramos Maldonado
2 documents · 2019
Cites 211.188 (batch production and control records) 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 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at REGI US INC?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected REGI US INC?
Emmanuel J. Ramos Maldonado is named on this Form 483, for the inspection of Jan 14 – Jan 15, 2019. Each investigator has a profile showing what they cite most.
When was REGI US INC inspected by FDA?
The inspection ran Jan 14 – Jan 15, 2019, and the Form 483 is dated January 15, 2019.
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.