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648845

Accel Inc — FEI 3003042119

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 24, 2009
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
New Albany, OH (United States)

Facility

Other inspections at this facility

  • 1196765 (NAI Fri Jan 27 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019852 (NAI Thu Jun 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1009628 (NAI Mon May 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 876483 (NAI Thu Apr 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 759169 (NAI Thu Dec 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
122721 CFR 211.67(c)Cleaning/maintenance records not kept
126321 CFR 211.68(b)Computer control of master formula records
178721 CFR 211.80(a)Procedures To Be in Writing
180121 CFR 211.84(a)Components withheld from use pending release