1091897

Schlotterbeck & Foss, LLC — FEI 1210017

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 4, 2019
Fiscal Year
2019
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Westbrook, ME (United States)

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
136121 CFR 211.100(a)Absence of Written Procedures
184221 CFR 211.84(d)(1)Component identity verification
184921 CFR 211.84(d)(6)Objectionable microbiological contamination
202721 CFR 211.192Investigations of discrepancies, failures
220321 CFR 211.186(b)(7)Theoretical Yield and Percentages
359121 CFR 211.110(b)In-process materials specifications
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies