FDA Inspection 839741 — Bio Tech Med Corp.
The FDA completed an inspection of Bio Tech Med Corp. on July 2, 2013 in San German, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 2, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San German, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12338 | 21 CFR 1271.180(b) | Review and approval-responsible person |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |