American Regent, Inc.
Form 483 issued April 24, 2024 · Shirley, New York
- Inspection
- Apr 10 – Apr 24, 2024
- Investigators
- Bijoy Panicker· Edmund F. Mrak
- Observations
- 7
- Pages
- 10
- FEI number
- 2410375
In short: On April 24, 2024, FDA issued a Form 483 with 7 observations to American Regent, Inc. in Shirley, New York (FEI 2410375) after an inspection that ran Apr 10 – Apr 24, 2024. The investigators were Bijoy Panicker and Edmund F. Mrak. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmAmerican Regent, 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 211.42(c)(10)(iii)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Regent, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and materials. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected American Regent, Inc.?
Bijoy Panicker and Edmund F. Mrak are named on this Form 483, for the inspection of Apr 10 – Apr 24, 2024. Each investigator has a profile showing what they cite most.
When was American Regent, Inc. inspected by FDA?
The inspection ran Apr 10 – Apr 24, 2024, and the Form 483 is dated April 24, 2024.
How do I get the full Form 483 for American Regent, Inc.?
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