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611743

ASI Marketing Group, LLC — FEI 3002442630

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 11, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Las Vegas, NV (United States)

Facility

Other inspections at this facility

  • 1064324 (VAI Fri Aug 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1024056 (VAI Tue Aug 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 857867 (VAI Mon Nov 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 674392 (VAI Thu Jul 22 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
113321 CFR 211.25(a)GMP Training Frequency
126121 CFR 211.68(a)Written calibration / inspection records not kept
136121 CFR 211.100(a)Absence of Written Procedures
139321 CFR 211.103Yield calculations not verified by 2nd person
141121 CFR 211.105(b)Distinctive ID or code not recorded in batch record
194321 CFR 211.180(e)(1)Review of representative number of batches
357021 CFR 211.100(a)Approval and review of procedures
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved