FDA Inspection
Lin, James P MD IncLin, James P MD Inc – FDA Inspection, Dec 24, 2013
Record Details
This FDA Inspection record concerns Lin, James P MD Inc, with an inspection on December 24, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Lin, James P MD Inc
- Inspection Date
- December 24, 2013
- Product Type
- Biologics
View Company Profile
ID · 6ea3123a-2c1e-490b-b2da-9b3756927456
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 859037
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
7- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.55(d)(1)Documentation maintained (general)
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.50(b)(2)Donor testing not negative for CD agents
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
- 21 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
- 21 CFR 1271.150(c)(1)(iii)Ensurane of compliance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Lin, James P MD Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| March 12, 2025 | VAI | Los Angeles District Office | Human Cellular, Tissue, and Gene Therapies |
| October 19, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 30, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 11, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| February 28, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Lin, James P MD Inc
- FDA Inspection 1263504 - 2025-03-12
- FDA Inspection 1182334 - 2022-10-19
- FDA Inspection 1034922 - 2017-10-30
- FDA Inspection 813194 - 2013-01-11
- FDA Inspection 712951 - 2011-02-28
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