Allegheny General Hospital
Form 483 issued December 17, 2015 · Pittsburgh, Pennsylvania
- Inspection
- Dec 3 – Dec 17, 2015
- Investigator
- Katelyn A. Staub-Zamperini
- Observations
- 6
- Pages
- 5
- FEI number
- 2521206
In short: On December 17, 2015, FDA issued a Form 483 with 6 observations to Allegheny General Hospital in Pittsburgh, Pennsylvania (FEI 2521206) after an inspection that ran Dec 3 – Dec 17, 2015. The investigator was Katelyn A. Staub-Zamperini. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.30 (if I am a user facility, what reporting requirements apply to me?).
At a glance
6 of 6 observations on this 483 concern capa.
Most cited: 21 CFR 803.30 (2×) · 803.17 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The user facility did not submit FDA Form 3500A or electronic equivalent to FDA and the…
- 02
The user facility did not submit FDA Form 3500A or electronic equivalent to the known device…
- 03
Written MDR procedures have…
- 04
MDR event files do not contain or reference all adverse event information in the possession of…
This inspection in context
Katelyn A. Staub-Zamperini
7 documents · 2014–2024
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmAllegheny General Hospital history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Allegheny General Hospital?
FDA listed 6 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.30 (if I am a user facility, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected Allegheny General Hospital?
Katelyn A. Staub-Zamperini is named on this Form 483, for the inspection of Dec 3 – Dec 17, 2015. Each investigator has a profile showing what they cite most.
When was Allegheny General Hospital inspected by FDA?
The inspection ran Dec 3 – Dec 17, 2015, and the Form 483 is dated December 17, 2015.
How do I get the full Form 483 for Allegheny General Hospital?
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.