FDA Inspection 649845 — Surgical Tissue Network, Inc.
The FDA completed an inspection of Surgical Tissue Network, Inc. on Mar 4, 2010 in Orlando, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 4, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12362 | 21 CFR 1271.195(b) | Corrective actions |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |