FDA Inspection 823088 — Industrial Woodworking Corp.

Industrial Woodworking Corp. — FEI 3003904216

The FDA completed an inspection of Industrial Woodworking Corp. on March 20, 2013 in Zeeland, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 20, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Zeeland, MI (United States)

Citations

IDCFRDescription
311821 CFR 820.75(a)Documentation
312321 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
316021 CFR 820.184Lack of or inadequate DHR procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
328521 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures