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814195

GVS TM, Inc — FEI 2013342

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 8, 2012
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Covina, CA (United States)

Facility

Other inspections at this facility

  • 1219069 (NAI Fri Sep 22 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1109177 (VAI Wed Sep 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053259 (NAI Tue May 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 891996 (NAI Tue Aug 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 715763 (NAI Fri Mar 18 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls
430321 CFR 211.67(b)Written procedures fail to include
431521 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
440921 CFR 211.194(a)(4)Data secured in course of each test