American Regent, Inc.
Form 483 issued April 11, 2018 · Shirley, New York
- Inspection
- Mar 19 – Apr 11, 2018
- Investigators
- Bijoy Panicker· Robert C. Horan
- Observations
- 2
- Pages
- 3
- FEI number
- 2410375
In short: On April 11, 2018, FDA issued a Form 483 with 2 observations to American Regent, Inc. in Shirley, New York (FEI 2410375) after an inspection that ran Mar 19 – Apr 11, 2018. The investigators were Bijoy Panicker and Robert C. Horan. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.113(b) (1×) · 211.25(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Employees are not given training in the particular operations they perform as…
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Regent, Inc.?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected American Regent, Inc.?
Bijoy Panicker and Robert C. Horan are named on this Form 483, for the inspection of Mar 19 – Apr 11, 2018. Each investigator has a profile showing what they cite most.
When was American Regent, Inc. inspected by FDA?
The inspection ran Mar 19 – Apr 11, 2018, and the Form 483 is dated April 11, 2018.
How do I get the full Form 483 for American Regent, 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.