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1022371

Defender SD Manufacturing LLC — FEI 1000135880

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 11, 2017
Fiscal Year
2017
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))
  • 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
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
202621 CFR 211.192Quality control unit review of records
355321 CFR 211.48(a)Plumbing System Defects
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
360321 CFR 211.160(b)Scientifically sound laboratory controls
439121 CFR 211.180(e)(2)Items to cover on annual reviews