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1173157

Akron Coating & Adhesives Inc — FEI 3002992168

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 27, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Akron, OH (United States)

Facility

Other inspections at this facility

  • 1085825 (VAI Wed Apr 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 856770 (VAI Wed Dec 04 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 719035 (NAI Tue Apr 19 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 595084 (VAI Thu Jul 02 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
136121 CFR 211.100(a)Absence of Written Procedures
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
188521 CFR 211.165(b)Microbiological testing
192021 CFR 211.166(a)(3)Valid stability test methods
192221 CFR 211.166(a)(4)Testing in same container - closure system
360321 CFR 211.160(b)Scientifically sound laboratory controls