Form 483 · FEI 3011292311
Form 483 issued September 23, 2022
- Inspection
- Sep 15 – Sep 23, 2022
- Investigators
- Gene Arey· Lewis K. Antwi
- Observations
- 1
- Pages
- 2
- FEI number
- 3011292311
In short: On September 23, 2022, FDA issued a Form 483 with 1 observation to an FDA-inspected site (FEI 3011292311) after an inspection that ran Sep 15 – Sep 23, 2022. The investigators were Gene Arey and Lewis K. Antwi. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
This inspection in context
Gene Arey
6 documents · 2015–2022
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in North Carolina.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Gene Arey and Lewis K. Antwi are named on this Form 483, for the inspection of Sep 15 – Sep 23, 2022. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Sep 15 – Sep 23, 2022, and the Form 483 is dated September 23, 2022.
How do I get the full Form 483 for an FDA-inspected site?
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.