FDA Inspection 882810 — Tissue Solutions, LLC.
The FDA completed an inspection of Tissue Solutions, LLC. on Jun 12, 2014 in Oklahoma City, OK. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 12, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Oklahoma City, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12417 | 21 CFR 1271.260(e) | Periodic review of temperatures |
| 12432 | 21 CFR 1271.265(e) | Documentation elements for activities |