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1180152

Defender SD Manufacturing LLC — FEI 1000135880

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 22, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
San Diego, CA (United States)

Facility

Other inspections at this facility

  • 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))
  • 837628 (VAI Tue Jun 18 2013 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
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
136121 CFR 211.100(a)Absence of Written Procedures
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
203121 CFR 211.194(a)Complete test data included in records
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action