FDA Inspection 583173 — Fertility Center And Applied Genetics Of Florida
The FDA completed an inspection of Fertility Center And Applied Genetics Of Florida on May 13, 2009 in Sarasota, 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
- May 13, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Sarasota, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12490 | 21 CFR 1271.85(b)(1) | Cell-associated CD |
| 15025 | 21 CFR 1271.85(b)(2) | Cytomegalovirus (CMV) |