American Regent, Inc.
Form 483 issued September 30, 2022 · New Albany, Ohio
- Inspection
- Sep 22 – Sep 30, 2022
- Investigator
- Andrew J. Barrowcliff
- Observations
- 1
- Pages
- 3
- FEI number
- 3010209784
In short: On September 30, 2022, FDA issued a Form 483 with 1 observation to American Regent, Inc. in New Albany, Ohio (FEI 3010209784) after an inspection that ran Sep 22 – Sep 30, 2022. The investigator was Andrew J. Barrowcliff. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Andrew J. Barrowcliff
5 documents · 2018–2023
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Regent, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected American Regent, Inc.?
Andrew J. Barrowcliff is named on this Form 483, for the inspection of Sep 22 – Sep 30, 2022. Each investigator has a profile showing what they cite most.
When was American Regent, Inc. inspected by FDA?
The inspection ran Sep 22 – Sep 30, 2022, and the Form 483 is dated September 30, 2022.
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.