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902146

Defender SD Manufacturing LLC — FEI 1000135880

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 3, 2014
Fiscal Year
2015
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))
  • 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
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
145121 CFR 211.113(b)Procedures for sterile drug products
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
360221 CFR 211.160(a)Deviations from laboratory control requirements
360321 CFR 211.160(b)Scientifically sound laboratory controls
439921 CFR 211.186(b)(7)Theoretical yield statement including percentages