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579363

3M Espe Dental Products — FEI 3005174370

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 13, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Saint Paul, MN (United States)

Facility

Other inspections at this facility

  • 1046452 (NAI Wed Mar 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 872250 (NAI Wed Mar 12 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 799456 (NAI Thu Sep 20 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 698056 (VAI Fri Nov 19 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
135821 CFR 211.100(b)SOPs not followed / documented
176721 CFR 211.137(a)Expiration date lacking
194321 CFR 211.180(e)(1)Review of representative number of batches
241921 CFR 211.198(a)Complaint Handling Procedure
358521 CFR 211.110(a)Control procedures to monitor and validate performance