American Regent Inc.
Form 483 issued March 8, 2019 · Hilliard, Ohio
- Inspection
- Feb 26 – Mar 8, 2019
- Investigator
- Ucheabuchi C. Chudi-Nwankwor
- Observations
- 2
- Pages
- 3
- FEI number
- 3005761472
In short: On March 8, 2019, FDA issued a Form 483 with 2 observations to American Regent Inc. in Hilliard, Ohio (FEI 3005761472) after an inspection that ran Feb 26 – Mar 8, 2019. The investigator was Ucheabuchi C. Chudi-Nwankwor. Most observations concern production; the most-cited regulation is 21 CFR 314.81 (other postmarketing reports).
At a glance
Observations span 1 system, led by production.
Most cited: 21 CFR 314.81(b)(1)(ii) (1×) · 211.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 02
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Ucheabuchi C. Chudi-Nwankwor
22 documents · 2016–2026
Cites 211.22 (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 314.81(b)(1)(ii)
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. The most-cited regulation is 21 CFR 314.81 (other postmarketing reports). The opening words of each observation are shown on this page.
Who inspected American Regent Inc.?
Ucheabuchi C. Chudi-Nwankwor is named on this Form 483, for the inspection of Feb 26 – Mar 8, 2019. Each investigator has a profile showing what they cite most.
When was American Regent Inc. inspected by FDA?
The inspection ran Feb 26 – Mar 8, 2019, and the Form 483 is dated March 8, 2019.
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.