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597980

JAS Diagnostics, Inc./Drew Scientific, Inc. — FEI 3003071743

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 14, 2009
Fiscal Year
2009
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Miami Lakes, FL (United States)

Facility

Other inspections at this facility

  • 1275275 (OAI Thu Jun 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1169174 (OAI Thu Apr 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100810 (NAI Thu Aug 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 898560 (VAI Thu Oct 02 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 713618 (VAI Fri Mar 04 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313821 CFR 820.130Packaging
334521 CFR 820.200(a)Servicing - Lack of or inadequate procedures
343221 CFR 820.75(b)(2)Documentation of validated process performance