752098

Avent, Inc. — FEI 3006646024

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 28, 2011
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Tucson, AZ (United States)

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
311821 CFR 820.75(a)Documentation
317221 CFR 820.198(c)Investigation of device failures
328621 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
343221 CFR 820.75(b)(2)Documentation of validated process performance
369621 CFR 820.100(b)Documentation