Home / Inspections / 581906

581906

Alere San Diego, Inc. — FEI 1000125596

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 8, 2009
Fiscal Year
2009
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
San Diego, CA (United States)

Facility

Other inspections at this facility

  • 1076303 (NAI Fri Jan 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 931956 (VAI Fri Jun 05 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 878268 (NAI Fri Jun 27 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 781860 (OAI Wed Jun 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
328421 CFR 820.90(a)Nonconforming product evaluation/investigation
336921 CFR 820.198(a)(1)Uniform and timely processing
73221 CFR 803.50(a)(2)Individual Report of Malfunction