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1137044

Spartan Chemical Co Inc — FEI 3001451695

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 26, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Maumee, OH (United States)

Facility

Other inspections at this facility

  • 1292502 (VAI Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1192745 (VAI Mon Dec 12 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 998397 (NAI Fri Dec 09 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
185121 CFR 211.84(e)Rejecting When Specifications Not Met
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
438821 CFR 211.198(a)Complaints reviewed by Quality Control Unit