FDA Inspection 1265604 — Elite IVF & Fertility Solutions LLC
The FDA completed an inspection of Elite IVF & Fertility Solutions LLC on Mar 28, 2025 in Odessa, TX. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 28, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Odessa, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12240 | 21 CFR 1271.55(b)(3) | Name and address on summary |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |