Home / Inspections / 1097808

1097808

FHC, Inc. — FEI 3002250546

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 24, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Bowdoin, ME (United States)

Facility

Other inspections at this facility

  • 1275315 (VAI Thu Jul 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 951669 (VAI Thu Oct 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 768395 (VAI Fri Feb 10 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 598208 (VAI Tue Jul 21 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471921 CFR 820.30(h)Incorrect translation to production specifications
263021 CFR 820.30(e)Design review - documentation
313021 CFR 820.100(a)Lack of or inadequate procedures