FDA Inspection 1062748 — South Florida Institute For Reproductive Medicine, P.A.
The FDA completed an inspection of South Florida Institute For Reproductive Medicine, P.A. on August 3, 2018 in South Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 3, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- South Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |