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1164713

Phoenix Diagnostics, Inc. — FEI 1222035

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
March 17, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Natick, MA (United States)

Facility

Other inspections at this facility

  • 1022108 (NAI Fri Aug 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 792557 (VAI Thu Jul 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 602295 (NAI Thu Aug 06 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures