American Regent Inc.
Form 483 issued July 20, 2023 · Hilliard, Ohio
- Inspection
- Jul 10 – Jul 20, 2023
- Observations
- 2
- Pages
- 3
- FEI number
- 3005761472
In short: On July 20, 2023, FDA issued a Form 483 with 2 observations to American Regent Inc. in Hilliard, Ohio (FEI 3005761472) after an inspection that ran Jul 10 – Jul 20, 2023. Most observations concern production and quality system.
At a glance
Production and quality system account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations from written production and process control procedures are…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
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 opening words of each observation are shown on this page.
When was American Regent Inc. inspected by FDA?
The inspection ran Jul 10 – Jul 20, 2023, and the Form 483 is dated July 20, 2023.
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.