Banner - University Medical Center
Form 483 issued April 22, 2026 · Tucson
- Inspection
- Apr 20 – Apr 22, 2026
- Investigator
- Emily S. McGann
- Observations
- 2
- Pages
- 2
In short: On April 22, 2026, FDA issued a Form 483 with 2 observations to Banner - University Medical Center in Tucson after an inspection that ran Apr 20 – Apr 22, 2026. The investigator was Emily S. McGann. Most observations concern biologics CGMP and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Biologics CGMP and quality system account for 2 of 2 observations.
Most cited: 21 CFR 606.160 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Records including signature by the physician requesting the procedure are not maintained of all emergency transfusions…
- 02
Failure to perform a thorough investigation and make a record of the conclusions and follow-up…
This inspection in context
Questions about this 483
What did FDA find at Banner - University Medical Center?
FDA listed 2 observations on this Form 483, mostly about biologics CGMP and quality system. 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 Banner - University Medical Center?
Emily S. McGann is named on this Form 483, for the inspection of Apr 20 – Apr 22, 2026. Each investigator has a profile showing what they cite most.
When was Banner - University Medical Center inspected by FDA?
The inspection ran Apr 20 – Apr 22, 2026, and the Form 483 is dated April 22, 2026.
How do I get the full Form 483 for Banner - University Medical Center?
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.