Rochester General Hospital
Form 483 issued February 9, 2015 · Rochester, New York
- Inspection
- Feb 7 – Feb 9, 2015
- Investigator
- Nicholas C. Mendiola
- Observations
- 1
- Pages
- 2
- FEI number
- 1371719
In short: On February 9, 2015, FDA issued a Form 483 with 1 observation to Rochester General Hospital in Rochester, New York (FEI 1371719) after an inspection that ran Feb 7 – Feb 9, 2015. The investigator was Nicholas C. Mendiola. 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 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written MDR procedures have…
This inspection in context
Nicholas C. Mendiola
4 documents · 2015–2018
Cites 803.17 (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 firmRochester General 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 Rochester General Hospital?
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 Rochester General Hospital?
Nicholas C. Mendiola is named on this Form 483, for the inspection of Feb 7 – Feb 9, 2015. Each investigator has a profile showing what they cite most.
When was Rochester General Hospital inspected by FDA?
The inspection ran Feb 7 – Feb 9, 2015, and the Form 483 is dated February 9, 2015.
How do I get the full Form 483 for Rochester 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.