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1162318

Human Biosciences, Inc. — FEI 3008770963

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
February 15, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Gaithersburg, MD (United States)

Facility

Other inspections at this facility

  • 1017351 (NAI Tue Jun 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 839569 (NAI Fri Jul 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 810166 (VAI Fri Jan 04 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 748491 (OAI Tue Oct 18 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
260421 CFR 820.30(e)Design review - Lack of or inadequate procedures
328521 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
367421 CFR 820.30(d)Design output - documentation