FDA Inspection 583184 — Specialists In Reproductive Medicine & Surgery, P.A.
The FDA completed an inspection of Specialists In Reproductive Medicine & Surgery, P.A. on May 14, 2009 in Fort Myers, 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 14, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fort Myers, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12283 | 21 CFR 1271.75(e) | Abbreviated procedure |