FDA Inspection
Lin, James P MD IncLin, James P MD Inc – FDA Inspection, Mar 12, 2025
Record Details
This FDA Inspection record concerns Lin, James P MD Inc, with an inspection on March 12, 2025, issued by the Los Angeles District Office, covering biologics.
View Company Profile
ID · 62664eb0-bc6b-4b3c-b6f0-faf954ad59a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1263504
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.55(b)(4)Reasons for ineligibility on summary
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.85(b)(2)Cytomegalovirus (CMV)
- 21 CFR 1271.90(c)Eligibility not required--warning labels
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 |
|---|---|---|---|
| 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 |
| December 24, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| 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 1182334 - 2022-10-19
- FDA Inspection 1034922 - 2017-10-30
- FDA Inspection 859037 - 2013-12-24
- FDA Inspection 813194 - 2013-01-11
- FDA Inspection 712951 - 2011-02-28
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.