BioTissue Holdings Inc
Form 483 issued February 18, 2026 · Doral, Florida
- Inspection
- Feb 9 – Feb 18, 2026
- Investigator
- Ronald Ifraimov
- Observations
- 3
- Pages
- 6
- FEI number
- 3009809074
In short: On February 18, 2026, FDA issued a Form 483 with 3 observations to BioTissue Holdings Inc in Doral, Florida (FEI 3009809074) after an inspection that ran Feb 9 – Feb 18, 2026. The investigator was Ronald Ifraimov. Most observations concern cAPA.
At a glance
Observations span 1 system, led by capa.
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within * of receiving or otherwise becoming aware of information…
- 02ISO 13485:2016 Clause 8.2.1
Information gathered in the feedback process does not adequately serve as potential input into risk management…
- 03ISO 13485:2016 Clause 8.5.2
Corrective action was not adequately taken to eliminate the cause of nonconformities in…
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 firmBioTissue Holdings Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.50(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BioTissue Holdings Inc?
FDA listed 3 observations on this Form 483, mostly about cAPA. The opening words of each observation are shown on this page.
Who inspected BioTissue Holdings Inc?
Ronald Ifraimov is named on this Form 483, for the inspection of Feb 9 – Feb 18, 2026. Each investigator has a profile showing what they cite most.
When was BioTissue Holdings Inc inspected by FDA?
The inspection ran Feb 9 – Feb 18, 2026, and the Form 483 is dated February 18, 2026.
How do I get the full Form 483 for BioTissue Holdings 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.