FDA Inspection 784704 — Surgical Tissue Network, Inc.
The FDA completed an inspection of Surgical Tissue Network, Inc. on Jun 20, 2012 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). 18 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 20, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12324 | 21 CFR 1271.160(b)(6) | Deviations--Investigation, documenting, trending |
| 12332 | 21 CFR 1271.170(b) | Qualifications lacking |
| 12373 | 21 CFR 1271.200(d) | Inspected routinely |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12427 | 21 CFR 1271.265(c)(3) | HCT/Ps made under departure from process |
| 12463 | 21 CFR 1271.320(c) | Documentation of decision not to investigate |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |