BioTissue Holdings Inc
FDA inspection history in Doral, Florida, 2026
- 1
- Form 483
Every document, by year
- Form 483
2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2026One Form 483, at Doral, Florida.
Cited most
Across all BioTissue Holdings observations on file
- ISO 13485:2016 Clause 8.2.11
- ISO 13485:2016 Clause 8.5.21
- 21 CFR 803.50(a)(1)If I am a manufacturer, what reporting requirements apply to me?1
The complete BioTissue Holdings file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Doral, Florida
One Form 483 · 2026 · 3 observations
Latest: Form 483, Feb 18, 2026 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-02-18 | 483 Form 483 | Doral, Florida | 3 | $99 |
Investigators on these documents
FEI number 3009809074 · most recent document Feb 18, 2026
About BioTissue Holdings Inc
How many FDA Form 483s has BioTissue Holdings Inc received?
FDA Intel has 1 Form 483 on file for BioTissue Holdings Inc; the most recent is dated Feb 18, 2026.
When was BioTissue Holdings Inc last inspected by FDA?
The most recent FDA inspection document on file for BioTissue Holdings Inc is a Form 483 dated Feb 18, 2026, for the site in Doral, Florida.
What did FDA cite at BioTissue Holdings Inc?
The regulations cited most in the observations on file for BioTissue Holdings Inc are ISO 13485:2016 Clause 8.2.1, 1 time; ISO 13485:2016 Clause 8.5.2, 1 time; 21 CFR 803.50(a)(1) (If I am a manufacturer, what reporting requirements apply to me?), 1 time.