American Regent, Inc.
Form 483 issued December 9, 2022 · New Albany, Ohio
- Observations
- 3
- Pages
- 3
- FEI number
- 3010209784
In short: On December 9, 2022, FDA issued a Form 483 with 3 observations to American Regent, Inc. in New Albany, Ohio (FEI 3010209784). Most observations concern quality system and production.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Employees engaged in the manufacture and processing of a drug product lack the training required to…
- 03
Written records of investigations into unexplained discrepancies or the failure of a batch or any of…
This inspection in context
Questions about this 483
What did FDA find at American Regent, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
When was American Regent, Inc. inspected by FDA?
This Form 483 is dated December 9, 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.