FDA Inspection 627284 — Viera Fertility Center
The FDA completed an inspection of Viera Fertility Center on November 12, 2009 in Melbourne, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 12, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Melbourne, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |