796961

Abbott Laboratories — FEI 1451914

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 24, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
North Chicago, IL (United States)

Citations

IDCFRDescription
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
312821 CFR 820.90(a)Nonconforming product control
313021 CFR 820.100(a)Lack of or inadequate procedures
317321 CFR 820.198(d)Evaluation, timeliness, identification
326221 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
342721 CFR 820.50(a)(2)Supplier oversight
73221 CFR 803.50(a)(2)Individual Report of Malfunction