FDA Inspection 1263504 — Lin, James P MD Inc. D.B.A. Reproductive Fertility Center
The FDA completed an inspection of Lin, James P MD Inc. D.B.A. Reproductive Fertility Center on Mar 12, 2025 in Irvine, 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). 6 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 12, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 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 |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |
| 15025 | 21 CFR 1271.85(b)(2) | Cytomegalovirus (CMV) |