FDA Inspection 1040962 — BioTissue Holdings Inc
The FDA completed an inspection of BioTissue Holdings Inc on February 6, 2018 in Doral, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 6, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12354 | 21 CFR 1271.190(d)(2) | Documentation of activities |
| 12362 | 21 CFR 1271.195(b) | Corrective actions |
| 12363 | 21 CFR 1271.195(c) | Monitoring--cross contamination, exposure to CD |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |
| 12375 | 21 CFR 1271.210(a) | Use prior to verification |
| 12387 | 21 CFR 1271.220(a) | Causing contamination, increasing risks |
| 12391 | 21 CFR 1271.220(c) | Sampling representative (in-process HCT/Ps) |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12473 | 21 CFR 1271.350(b)(2) | Deviations not reported to FDA |