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1192745

Spartan Chemical Co Inc — FEI 3001451695

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 12, 2022
Fiscal Year
2023
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))
  • 1137044 (OAI Fri Mar 26 2021 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
126321 CFR 211.68(b)Computer control of master formula records
187921 CFR 211.180(c)Records not made readily available to FDA
360321 CFR 211.160(b)Scientifically sound laboratory controls
431421 CFR 211.84(d)(2)Reports of Analysis (Components)