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768395

FHC, Inc. — FEI 3002250546

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 10, 2012
Fiscal Year
2012
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))
  • 1097808 (VAI Wed Jul 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 951669 (VAI Thu Oct 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 598208 (VAI Tue Jul 21 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471021 CFR 820.150Lack of or inadequate procedures for storage.
1471621 CFR 820.30(f)Design verification - output does not meet input requirement
232821 CFR 820.22Quality audits - auditor independence
311821 CFR 820.75(a)Documentation
313821 CFR 820.130Packaging
319021 CFR 820.30(g)Design validation acceptance criteria
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
368321 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
369621 CFR 820.100(b)Documentation
53721 CFR 820.70(a)Production processes