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1026753

Ludwig Medical, Inc — FEI 1419537

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 26, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Effingham, IL (United States)

Facility

Other inspections at this facility

  • 780305 (NAI Mon May 07 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 697474 (NAI Mon Nov 08 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1472221 CFR 820.40Procedures not adequately established or maintained
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures