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1085825

Akron Coating & Adhesives Inc — FEI 3002992168

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 10, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Akron, OH (United States)

Facility

Other inspections at this facility

  • 1173157 (VAI Mon Jun 27 2022 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
136121 CFR 211.100(a)Absence of Written Procedures
162921 CFR 211.130(a)Prevention of cross contamination, mix-ups
183321 CFR 211.84(d)(1)Identity Testing of Each Component
191221 CFR 211.166(a)Written program not followed
191421 CFR 211.166(a)Lack of written stability program
192621 CFR 211.166(b)Adequate number of batches on stability