Circulatory Technology Inc
Form 483 issued July 8, 2016 · Oyster Bay, New York
- Inspection
- Jun 6 – Jul 8, 2016
- Investigator
- Ronald Ifraimov
- Observations
- 10
- Pages
- 7
- FEI number
- 1000522036
In short: On July 8, 2016, FDA issued a Form 483 with 10 observations to Circulatory Technology Inc in Oyster Bay, New York (FEI 1000522036) after an inspection that ran Jun 6 – Jul 8, 2016. The investigator was Ronald Ifraimov. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and design controls account for 8 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
A submitted MDR event was not evaluated in accordance with the requirements of the regulations regarding…
- 0321 CFR 820.30(j)21 CFR 820
The design history file was not established and does not demonstrate that the design was developed…
- 04
Design plans that describe or reference the design and development activities and define responsibility for implementation…
This inspection in context
Ronald Ifraimov
10 documents · 2014–2026
Cites 820.30(b) (design controls) more than any other section. Most of their documents are for sites in Florida.
The firmCirculatory Technology Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 803.50(a)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Circulatory Technology Inc?
FDA listed 10 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Circulatory Technology Inc?
Ronald Ifraimov is named on this Form 483, for the inspection of Jun 6 – Jul 8, 2016. Each investigator has a profile showing what they cite most.
When was Circulatory Technology Inc inspected by FDA?
The inspection ran Jun 6 – Jul 8, 2016, and the Form 483 is dated July 8, 2016.
How do I get the full Form 483 for Circulatory Technology Inc?
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.