FDA Inspection 859037 — 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 Dec 24, 2013 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). 7 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 24, 2013
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12232 | 21 CFR 1271.50(b)(2) | Donor testing not negative for CD agents |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12243 | 21 CFR 1271.55(d)(1) | Documentation maintained (general) |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |