FDA Inspection
Scientific Medical Systems/Idant LaboratoriesScientific Medical Systems/Idant Laboratories – FDA Inspection, Jul 2, 2015
Record Details
This FDA Inspection record concerns Scientific Medical Systems/Idant Laboratories, with an inspection on July 2, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 2, 2015
- Product Type
- Biologics
View Company Profile
ID · 9ae6aa55-e015-4d08-ac30-e0976ebfa068
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 931004
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Scientific Medical Systems/Idant Laboratories
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2014 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 8, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 13, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 9, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Scientific Medical Systems/Idant Laboratories
- FDA Inspection 905629 - 2014-12-12
- FDA Inspection 813868 - 2013-01-08
- FDA Inspection 762341 - 2012-01-13
- FDA Inspection 631783 - 2009-12-09
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.