FDA Inspection 1304322 — BioTissue Holdings Inc
The FDA completed an inspection of BioTissue Holdings Inc on February 18, 2026 in Doral, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 18, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23213 | ISO 13485:2016 Clause 8.2.1 | Information gathered in feedback process not used as input into risk management |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |