FDA Inspection 1112244 — Dallas IVF
The FDA completed an inspection of Dallas IVF on December 9, 2019 in Frisco, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 9, 2019
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Frisco, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12437 | 21 CFR 1271.270(a) | Records incomplete |
| 12496 | 21 CFR 1271.85(b)(2) | SOP for release; reactive for CMV |