FDA Inspection 680725 — La Jolla IVF
The FDA completed an inspection of La Jolla IVF on September 17, 2010 in La Jolla, 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
- September 17, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- La Jolla, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |