FDA Inspection 987767 — Fertility and IVF Center of Miami Inc
The FDA completed an inspection of Fertility and IVF Center of Miami Inc on September 27, 2016 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 27, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12231 | 21 CFR 1271.50(b)(1) | Donor screening standards |
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 12248 | 21 CFR 1271.55(d)(2) | Information, English or translated-authenticity |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |