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865402

DimcoGray Inc. — FEI 3007428065

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
February 7, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Centerville, OH (United States)

Facility

Other inspections at this facility

  • 1197616 (VAI Thu Feb 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1096699 (NAI Fri Jun 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1066895 (OAI Mon Sep 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1008218 (NAI Mon Apr 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
311921 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
53721 CFR 820.70(a)Production processes
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures