824521

Richard Wolf Medical Instruments Corp. — FEI 1418479

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 8, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Vernon Hills, IL (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
342721 CFR 820.50(a)(2)Supplier oversight
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
73121 CFR 803.50(a)(1)Report of Death or Serious Injury
73221 CFR 803.50(a)(2)Individual Report of Malfunction