FDA Inspection 566821 — 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 January 15, 2009 in Irvine, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 15, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12236 | 21 CFR 1271.55(a)(2) | Eligibility statement--basis of determination |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12240 | 21 CFR 1271.55(b)(3) | Name and address on summary |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12287 | 21 CFR 1271.80(c) | Kits not FDA approved, specifically labeled |
| 12290 | 21 CFR 1271.80(d)(1) | Reactive tests--not determined ineligible |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |