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592803

Consolidated Chemical, Inc — FEI 1940465

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 12, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Saint Louis, MO (United States)

Facility

Other inspections at this facility

  • 1176310 (OAI Tue Aug 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100757 (OAI Fri Aug 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 990242 (OAI Tue Oct 25 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 917115 (VAI Tue Mar 24 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 800697 (VAI Mon Sep 17 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

  • Injunction (72) (Tue Sep 08 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
136121 CFR 211.100(a)Absence of Written Procedures
138821 CFR 211.101(d)Component addition checked by 2nd person
145021 CFR 211.113(a)Procedures for non-sterile drug products
145421 CFR 211.115(a)Reprocessing procedures not written or followed
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
189021 CFR 211.165(e)Test methods
194321 CFR 211.180(e)(1)Review of representative number of batches
200921 CFR 211.188Prepared for each batch, include complete information
202721 CFR 211.192Investigations of discrepancies, failures
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
358521 CFR 211.110(a)Control procedures to monitor and validate performance
440221 CFR 211.192Written record of investigation incomplete