University of Rochester Medical Center
Form 483 issued January 29, 2016 · Rochester, New York
- Inspection
- Jan 26 – Jan 29, 2016
- Investigator
- Harry J. Brewer
- Observations
- 1
- Pages
- 3
- FEI number
- 3003684822
In short: On January 29, 2016, FDA issued a Form 483 with 1 observation to University of Rochester Medical Center in Rochester, New York (FEI 3003684822) after an inspection that ran Jan 26 – Jan 29, 2016. The investigator was Harry J. Brewer. 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
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 803.17(b)(4) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The written MDR procedure does not include documentation and recordkeeping requirements for systems that ensure access…
This inspection in context
Harry J. Brewer
1 document · 2016
Cites 803.17(b)(4) (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in New York.
The firmUniversity of Rochester Medical Center history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17(b)(4)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at University of Rochester Medical Center?
FDA listed 1 observation 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 University of Rochester Medical Center?
Harry J. Brewer is named on this Form 483, for the inspection of Jan 26 – Jan 29, 2016. Each investigator has a profile showing what they cite most.
When was University of Rochester Medical Center inspected by FDA?
The inspection ran Jan 26 – Jan 29, 2016, and the Form 483 is dated January 29, 2016.
How do I get the full Form 483 for University of Rochester 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.