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FDA Inspection
•Scientific Medical Systems/Idant Laboratories•December 9, 2009

Scientific Medical Systems/Idant Laboratories – FDA Inspection, Dec 9, 2009

Record Details

This FDA Inspection record concerns Scientific Medical Systems/Idant Laboratories, with an inspection on December 9, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Scientific Medical Systems/Idant Laboratories
Inspection Date
December 9, 2009
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 956acf26-bb9b-47c1-b914-6abc8d2dd972

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
631783
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

2
  1. 21 CFR 1271.47(a)Procedures for all other requirements
  2. 21 CFR 820.75(a)Documentation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Scientific Medical Systems/Idant Laboratories

4
DateClassificationOfficeProject area
July 2, 2015VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
December 12, 2014OAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
January 8, 2013NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 13, 2012VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Scientific Medical Systems/Idant Laboratories
  • FDA Inspection 931004 - 2015-07-02
  • FDA Inspection 905629 - 2014-12-12
  • FDA Inspection 813868 - 2013-01-08
  • FDA Inspection 762341 - 2012-01-13

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