Form 483 · FEI 3014307835
Form 483 issued September 5, 2025 · Phoenix, Arizona
- Inspection
- Aug 18 – Sep 5, 2025
- Investigators
- Homero W. Aguilar· Roger F. Zabinski
- Observations
- 8
- Pages
- 15
- FEI number
- 3014307835
In short: On September 5, 2025, FDA issued a Form 483 with 8 observations to an FDA-inspected site in Phoenix, Arizona (FEI 3014307835) after an inspection that ran Aug 18 – Sep 5, 2025. The investigators were Homero W. Aguilar and Roger F. Zabinski. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and materials account for 5 of 8 observations.
Most cited: 21 CFR 211.192 (2×) · 211.84(d)(2) (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Component testing is deficient in that each component is not tested for conformity with all appropriate…
- 03
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 04
Written records of investigations into the failure of a batch or any of its components to…
This inspection in context
Homero W. Aguilar
8 documents · 2023–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmSite history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 8 observations on this Form 483, mostly about quality system, materials and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Homero W. Aguilar and Roger F. Zabinski are named on this Form 483, for the inspection of Aug 18 – Sep 5, 2025. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Aug 18 – Sep 5, 2025, and the Form 483 is dated September 5, 2025.
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.