Form 483 · FEI 3004010435
Form 483 issued September 6, 2024 · Salt Lake City, Utah
- Inspection
- Sep 3 – Sep 6, 2024
- Investigator
- Joey V. Quitania
- Observations
- 1
- Pages
- 2
- FEI number
- 3004010435
In short: On September 6, 2024, FDA issued a Form 483 with 1 observation to an FDA-inspected site in Salt Lake City, Utah (FEI 3004010435) after an inspection that ran Sep 3 – Sep 6, 2024. The investigator was Joey V. Quitania. Most observations concern quality system; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.180 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You did not follow…
This inspection in context
Joey V. Quitania
23 documents · 2009–2026
Cites 211.113 (control of microbiological contamination) 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 211.180
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 quality system. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Joey V. Quitania is named on this Form 483, for the inspection of Sep 3 – Sep 6, 2024. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Sep 3 – Sep 6, 2024, and the Form 483 is dated September 6, 2024.
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.