FDA Inspection
Lin, James P MD IncLin, James P MD Inc – FDA Inspection, Jan 15, 2009
Record Details
This FDA Inspection record concerns Lin, James P MD Inc, with an inspection on January 15, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Lin, James P MD Inc
- Inspection Date
- January 15, 2009
- Product Type
- Biologics
View Company Profile
ID · 1ae86341-833f-47f7-9498-9b546538a1c0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 566821
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
11- 21 CFR 1271.55(a)(2)Eligibility statement--basis of determination
- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.47(b)Review and approval of procedures
- 21 CFR 1271.80(b)Specimen collections not timely
- 21 CFR 1271.80(d)(1)Reactive tests--not determined ineligible
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.55(b)(2)Listing and interpretation of CD tests performed
- 21 CFR 1271.55(b)(3)Name and address on summary
Showing 10 of 11 citations.
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 |
| 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 |
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 859037 - 2013-12-24
- FDA Inspection 813194 - 2013-01-11
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.