Form 483 · FEI 3007200605
Form 483 issued December 2, 2014 · Mesa, Arizona
- Inspection
- Nov 18 – Dec 2, 2014
- Investigators
- Joey V. Quitania· Paul A. Bonneau
- Observations
- 3
- Pages
- 2
- FEI number
- 3007200605
In short: On December 2, 2014, FDA issued a Form 483 with 3 observations to an FDA-inspected site in Mesa, Arizona (FEI 3007200605) after an inspection that ran Nov 18 – Dec 2, 2014. The investigators were Joey V. Quitania and Paul A. Bonneau. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.28 (personnel responsibilities).
At a glance
Production and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.28 (1×) · 211.166 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 02
Protective apparel is not worn as necessary to protect…
- 03
There is no written testing program designed to assess the stability…
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
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.28
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 3 observations on this Form 483, mostly about production and laboratory controls. The most-cited regulation is 21 CFR 211.28 (personnel responsibilities). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Joey V. Quitania and Paul A. Bonneau are named on this Form 483, for the inspection of Nov 18 – Dec 2, 2014. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Nov 18 – Dec 2, 2014, and the Form 483 is dated December 2, 2014.
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.