1195234

AgroChem USA, LLC — FEI 3005566735

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 13, 2023
Fiscal Year
2023
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Saratoga Springs, NY (United States)

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
191421 CFR 211.166(a)Lack of written stability program
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
363221 CFR 211.170(b)Annual visual exams of drug products
431521 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs