Form 483
Form 483 issued February 28, 2022 · Irwindale, California
- Inspection
- Feb 7 – Feb 28, 2022
- Investigator
- T. G. Tsiou
- Observations
- 4
- Pages
- 7
- FEI number
- 3003102569
In short: On February 28, 2022, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Irwindale, California (FEI 3003102569) after an inspection that ran Feb 7 – Feb 28, 2022. The investigator was T. G. Tsiou. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.25 (personnel).
At a glance
Production & process controls and capa account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Proc identifying product during all stages of receipt, production, distribution, and installation have…
- 02
Complaint files are not…
- 03
Acceptance or rejection of incoming…
- 04
The quality system record has…
This inspection in context
T. G. Tsiou
1 document · 2022
Cites 820.120 (device labeling) more than any other section. Most of their documents are for sites in California.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.60
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 4 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The most-cited regulation is 21 CFR 820.25 (personnel). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
T. G. Tsiou is named on this Form 483, for the inspection of Feb 7 – Feb 28, 2022. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Feb 7 – Feb 28, 2022, and the Form 483 is dated February 28, 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.