Indiana University Hospital
Form 483 issued February 3, 2016 · Indianapolis, Indiana
- Inspection
- Dec 15, 2015 – Feb 3, 2016
- Investigator
- Joseph R. Strelnik
- Observations
- 2
- Pages
- 4
- FEI number
- 3004492321
In short: On February 3, 2016, FDA issued a Form 483 with 2 observations to Indiana University Hospital in Indianapolis, Indiana (FEI 3004492321) after an inspection that ran Dec 15, 2015 – Feb 3, 2016. The investigator was Joseph R. Strelnik. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 803.17 (1×) · 803.18 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written MDR Procedme does not include an intemal system which provides for the timely and…
- 02
MDR event files have not…
This inspection in context
Joseph R. Strelnik
13 documents · 2011–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Indiana.
The firmIndiana University Hospital history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Indiana University Hospital?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?). The opening words of each observation are shown on this page.
Who inspected Indiana University Hospital?
Joseph R. Strelnik is named on this Form 483, for the inspection of Dec 15, 2015 – Feb 3, 2016. Each investigator has a profile showing what they cite most.
When was Indiana University Hospital inspected by FDA?
The inspection ran Dec 15, 2015 – Feb 3, 2016, and the Form 483 is dated February 3, 2016.
How do I get the full Form 483 for Indiana University 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.