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665791

BioCheck, Inc. — FEI 3002564473

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 9, 2010
Fiscal Year
2010
Product Type
Devices
Project Area
Compliance: Devices
Location
South San Francisco, CA (United States)

Facility

Other inspections at this facility

  • 1204769 (NAI Tue Feb 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1060644 (NAI Thu Jul 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 904632 (NAI Fri Dec 12 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 730360 (NAI Fri Jun 17 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471121 CFR 820.160(a)Lack of or inadequate procedures for distribution
255721 CFR 820.30(c)Design input - documentation
310421 CFR 820.30(j)Design history file
319121 CFR 820.30(g)Design validation - production units
320121 CFR 820.40(a)Not approved or obsolete document retrieval