American Medical Endoscopy, Inc
Form 483 issued October 11, 2023 · Doral, Florida
- Inspection
- Oct 10 – Oct 11, 2023
- Investigator
- Ronald Ifraimov
- Observations
- 1
- Pages
- 3
- FEI number
- 3004361445
In short: On October 11, 2023, FDA issued a Form 483 with 1 observation to American Medical Endoscopy, Inc in Doral, Florida (FEI 3004361445) after an inspection that ran Oct 10 – Oct 11, 2023. The investigator was Ronald Ifraimov. 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 observation- 01
Written MDR procedures have…
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 firmAmerican Medical Endoscopy, Inc 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 American Medical Endoscopy, Inc?
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 American Medical Endoscopy, Inc?
Ronald Ifraimov is named on this Form 483, for the inspection of Oct 10 – Oct 11, 2023. Each investigator has a profile showing what they cite most.
When was American Medical Endoscopy, Inc inspected by FDA?
The inspection ran Oct 10 – Oct 11, 2023, and the Form 483 is dated October 11, 2023.
How do I get the full Form 483 for American Medical Endoscopy, 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.