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1265533

Acme United Corporation — FEI 3012129555

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 28, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Brooksville, FL (United States)

Facility

Other inspections at this facility

  • 1081814 (VAI Fri Mar 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1012163 (VAI Fri May 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
126121 CFR 211.68(a)Written calibration / inspection records not kept
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
188521 CFR 211.165(b)Microbiological testing
202721 CFR 211.192Investigations of discrepancies, failures
358221 CFR 211.105(a)Identification of containers, lines, equipment