FDA Inspection 1045690 — ART Reproductive Center, LLC
The FDA completed an inspection of ART Reproductive Center, LLC on March 23, 2018 in Beverly Hills, CA. 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
- March 23, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Beverly Hills, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |