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1094523

DDC Technologies, Inc. — FEI 3002757272

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 28, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Oceanside, NY (United States)

Facility

Other inspections at this facility

  • 1248514 (NAI Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1156159 (VAI Fri Oct 22 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1115002 (VAI Wed Jan 08 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1034820 (VAI Thu Dec 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 948368 (VAI Mon Nov 09 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
237121 CFR 820.30(a)Design control - no procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
341521 CFR 820.22Quality Audit/Reaudit - conducted
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency
500721 CFR 1002.13Failure to submit
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures