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837628

Defender SD Manufacturing LLC — FEI 1000135880

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 18, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
San Diego, CA (United States)

Facility

Other inspections at this facility

  • 1180152 (OAI Thu Sep 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1043973 (OAI Mon Mar 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1022371 (VAI Thu May 11 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 902146 (VAI Mon Nov 03 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 766915 (NAI Thu Feb 09 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
108621 CFR 211.22(b)Adequate lab facilities not available
126321 CFR 211.68(b)Computer control of master formula records
143321 CFR 211.42(c)(10)(iii)Air Supply
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
360321 CFR 211.160(b)Scientifically sound laboratory controls