677276

E.A. Beck & Co. — FEI 2080222

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 25, 2010
Fiscal Year
2010
Product Type
Devices
Project Area
Compliance: Devices
Location
Schaumburg, IL (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
313021 CFR 820.100(a)Lack of or inadequate procedures
313221 CFR 820.120Lack of or inadequate procedures for labeling
316021 CFR 820.184Lack of or inadequate DHR procedures
326321 CFR 820.250(b)Sampling plans
333121 CFR 820.181DMR - not or inadequately maintained
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation
63021 CFR 803.17Lack of Written MDR Procedures