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1035357

Schlotterbeck & Foss, LLC — FEI 1210017

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 18, 2017
Fiscal Year
2018
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Westbrook, ME (United States)

Facility

Other inspections at this facility

  • 1160046 (NAI Thu Dec 23 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1091897 (VAI Tue Jun 04 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1027145 (NAI Mon Sep 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 866837 (NAI Tue Jan 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 770663 (NAI Thu Feb 23 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
119421 CFR 211.42(c)Defined areas of adequate size for operations
138821 CFR 211.101(d)Component addition checked by 2nd person
172821 CFR 211.87Retest of approved components/containers/closures
188321 CFR 211.165(a)Testing and release for distribution
189021 CFR 211.165(e)Test methods
189121 CFR 211.165(f)Failing drug products not rejected
191421 CFR 211.166(a)Lack of written stability program
199921 CFR 211.184(a)Record information required
202721 CFR 211.192Investigations of discrepancies, failures
431521 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs