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709731

Defender SD Manufacturing LLC — FEI 1000135880

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 2, 2011
Fiscal Year
2011
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))
  • 837628 (VAI Tue Jun 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
109821 CFR 211.22(c)Approve or reject procedures or specs
122421 CFR 211.67(b)(6)Cleaning SOP/inspection
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
139621 CFR 211.42(c)(2)Rejected Material Area
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products
154021 CFR 211.125(a)Strict control not exercised over labeling issued
200321 CFR 211.184(c)Individual inventory record
434221 CFR 211.142(b)Storage under appropriate conditions