FDA Inspection 1146643 — IVF Laboratory of Central Florida LLC
The FDA completed an inspection of IVF Laboratory of Central Florida LLC on July 14, 2021 in Winter Park, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 14, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Winter Park, 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 |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |