FDA Inspection 1279765 — IVF Virginia LLC
The FDA completed an inspection of IVF Virginia LLC on Aug 18, 2025 in Chesapeake, VA. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 18, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Chesapeake, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |