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886734

CCRM DFW — FEI 3008234883

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 10, 2014
Fiscal Year
2014
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Frisco, TX (United States)

Facility

Other inspections at this facility

  • 1282798 (NAI Thu Sep 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1114052 (NAI Wed Dec 04 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023819 (NAI Tue Jul 25 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019066 (VAI Tue Jul 25 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 886733 (VAI Thu Jul 10 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1228621 CFR 1271.80(b)Specimen collections not timely
1228721 CFR 1271.80(c)Kits not FDA approved, specifically labeled