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1016932

Hand Biomechanics Lab, Inc. — FEI 2919128

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 5, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Sacramento, CA (United States)

Facility

Other inspections at this facility

  • 1049247 (VAI Wed Apr 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 904203 (NAI Thu Nov 20 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 641526 (NAI Wed Jan 27 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
311921 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
313021 CFR 820.100(a)Lack of or inadequate procedures
343321 CFR 820.75(c)Process changes - review, evaluation and revalidation
54621 CFR 820.75(a)Lack of or inadequate process validation
73121 CFR 803.50(a)(1)Report of Death or Serious Injury