FDA Inspection 810356 — UMTB
The FDA completed an inspection of UMTB on Nov 20, 2012 in Largo, 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
- Nov 20, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Largo, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12351 | 21 CFR 1271.190(d)(1) | Procedures for cleaning, sanitation |
| 12354 | 21 CFR 1271.190(d)(2) | Documentation of activities |
| 15020 | 21 CFR 1271.200(e) | Documentation of maintenance and cleaning |