New York Presbyterian Hospital
Form 483 issued December 10, 2015 · New York, New York
- Inspection
- Dec 10, 2015
- Investigators
- Andrew Garufi· Ronald Ifraimov
- Observations
- 2
- Pages
- 4
- FEI number
- 1000521590
In short: On December 10, 2015, FDA issued a Form 483 with 2 observations to New York Presbyterian Hospital in New York, New York (FEI 1000521590) after an inspection that ran Dec 10, 2015. The investigators were Andrew Garufi and Ronald Ifraimov. 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
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 803.30(a)(1) (1×) · 803.17 (1×)
What FDA observed
Preview: the opening words of each observation- 01
The user facility did not submit FDA Form 3500A or electr ~nic equivalent to FDA within…
- 02
Written MDR procedures have not been…
This inspection in context
Andrew Garufi
11 documents · 2015–2025
Cites 820.80(b) (receiving, in-process, and finished device acceptance) more than any other section. Most of their documents are for sites in New York.
The firmNew York Presbyterian Hospital history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.30(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at New York Presbyterian Hospital?
FDA listed 2 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 New York Presbyterian Hospital?
Andrew Garufi and Ronald Ifraimov are named on this Form 483, for the inspection of Dec 10, 2015. Each investigator has a profile showing what they cite most.
When was New York Presbyterian Hospital inspected by FDA?
The inspection ran Dec 10, 2015, and the Form 483 is dated December 10, 2015.
How do I get the full Form 483 for New York Presbyterian 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.