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1055131

Criticare Technologies, Inc. — FEI 3012238587

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 11, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Warwick, RI (United States)

Facility

Other inspections at this facility

  • 1289170 (OAI Tue Oct 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1238217 (NAI Fri May 10 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107892 (VAI Tue Oct 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1006521 (OAI Wed Mar 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
328621 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
334521 CFR 820.200(a)Servicing - Lack of or inadequate procedures