UCLA Ronald Reagan Medical Center
Form 483 issued December 18, 2015 · Los Angeles, California
- Inspection
- Dec 10 – Dec 18, 2015
- Investigator
- A. B. Belos
- Observations
- 2
- Pages
- 2
- FEI number
- 3007967308
In short: On December 18, 2015, FDA issued a Form 483 with 2 observations to UCLA Ronald Reagan Medical Center in Los Angeles, California (FEI 3007967308) after an inspection that ran Dec 10 – Dec 18, 2015. The investigator was A. B. Belos. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.32 (if I am a user facility, what information must I submit in my individual adverse event reports?).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 803.32 (1×) · 803.30 (1×)
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 failed to provide all information concerning individual adverse event reports that is reasonably…
- 02
The user facility did not submit FDA Form 3500A or electronic equivalent to the .known device…
This inspection in context
A. B. Belos
1 document · 2015
Cites 803.30 (if i am a user facility, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in California.
The firmUCLA Ronald Reagan Medical Center history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.32
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at UCLA Ronald Reagan Medical Center?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.32 (if I am a user facility, what information must I submit in my individual adverse event reports?). The opening words of each observation are shown on this page.
Who inspected UCLA Ronald Reagan Medical Center?
A. B. Belos is named on this Form 483, for the inspection of Dec 10 – Dec 18, 2015. Each investigator has a profile showing what they cite most.
When was UCLA Ronald Reagan Medical Center inspected by FDA?
The inspection ran Dec 10 – Dec 18, 2015, and the Form 483 is dated December 18, 2015.
How do I get the full Form 483 for UCLA Ronald Reagan 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.