FDA Inspection 1260056 — Reproductive Science Center Of The San Francisco Bay Area, A Medical Corporation
The FDA completed an inspection of Reproductive Science Center Of The San Francisco Bay Area, A Medical Corporation on Feb 5, 2025 in San Ramon, 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
- Feb 5, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Ramon, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |