FDA Inspection 1069504 — Los Angeles IVF Laboratory
The FDA completed an inspection of Los Angeles IVF Laboratory on Oct 19, 2018 in Encino, CA. 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
- Oct 19, 2018
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Encino, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12237 | 21 CFR 1271.55(a)(3) | Summary--records used to make determination |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |