American Regent, Inc.
Form 483 issued March 5, 2026 · Columbus, Ohio
- Inspection
- Mar 2 – Mar 5, 2026
- Investigator
- Lisa R. Hilliard
- Observations
- 2
- Pages
- 4
- FEI number
- 3003433784
In short: On March 5, 2026, FDA issued a Form 483 with 2 observations to American Regent, Inc. in Columbus, Ohio (FEI 3003433784) after an inspection that ran Mar 2 – Mar 5, 2026. The investigator was Lisa R. Hilliard. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Lisa R. Hilliard
15 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ohio.
The firmAmerican Regent, Inc. history
The site's inspection history, in date order.
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 2 observations 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.?
Lisa R. Hilliard is named on this Form 483, for the inspection of Mar 2 – Mar 5, 2026. Each investigator has a profile showing what they cite most.
When was American Regent, Inc. inspected by FDA?
The inspection ran Mar 2 – Mar 5, 2026, and the Form 483 is dated March 5, 2026.
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.