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628897

Collagen Matrix, Inc. — FEI 3003300673

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 10, 2009
Fiscal Year
2010
Product Type
Devices
Project Area
Compliance: Devices
Location
Allendale, NJ (United States)

Facility

Other inspections at this facility

  • 1021261 (NAI Thu Jul 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 961411 (OAI Wed Nov 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 758803 (VAI Mon Dec 05 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
265021 CFR 820.30(f)Design verification - Lack of or inadequate procedures
319121 CFR 820.30(g)Design validation - production units
337921 CFR 820.198(e)(5)Nature and details of complaint
369221 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
54621 CFR 820.75(a)Lack of or inadequate process validation