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709392

Hyperbaric Technologies Inc. — FEI 1000624398

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
February 4, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Amsterdam, NY (United States)

Facility

Other inspections at this facility

  • 1066879 (VAI Wed Sep 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 819582 (NAI Wed Feb 20 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 578886 (VAI Tue May 12 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471421 CFR 820.30(c)Design input - Lack of or inadequate procedures
1471521 CFR 820.30(d)Design output - Lack of or inadequate procedures
243021 CFR 820.30(b)Design plans - Lack of or inadequate
260421 CFR 820.30(e)Design review - Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures