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800812

Cook Children's Medical Center (CCMC) — FEI 1000138494

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 27, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Fort Worth, TX (United States)

Facility

Other inspections at this facility

  • 1258391 (NAI Wed Jan 08 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1121119 (NAI Fri Feb 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1050595 (NAI Thu Feb 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 963417 (NAI Tue Mar 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 882366 (NAI Mon Jun 09 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1503021 CFR 606.60(b)Equipment calibration frequency
15421 CFR 606.160(a)(1)Concurrent documentation
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
9821 CFR 606.100(c)Thorough investigations