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946597

Accu Bio-Chem Laboratories LLC — FEI 3004876794

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 29, 2015
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Glendale, CA (United States)

Facility

Other inspections at this facility

  • 1244664 (VAI Tue Jul 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1199608 (OAI Fri Feb 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1150437 (OAI Tue Aug 31 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 733576 (NAI Thu Jul 07 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 673181 (VAI Tue Jul 06 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
135821 CFR 211.100(b)SOPs not followed / documented
197521 CFR 211.182Written records kept in individual logs
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
356521 CFR 211.58Buildings not maintained in good state of repair
360321 CFR 211.160(b)Scientifically sound laboratory controls
361321 CFR 211.160(b)(4)Establishment of calibration procedures
439121 CFR 211.180(e)(2)Items to cover on annual reviews
440221 CFR 211.192Written record of investigation incomplete
440321 CFR 211.194(b)Test method modification records do not include