FDA Inspection 1204431 — Incinta Fertility Center, LLC
The FDA completed an inspection of Incinta Fertility Center, LLC on May 2, 2023 in Torrance, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 2, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Torrance, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12252 | 21 CFR 1271.60(a) | Completion of eligibility determination |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |