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777132

Alliance Medical Products, Inc. — FEI 2027189

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 16, 2012
Fiscal Year
2012
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Irvine, CA (United States)

Facility

Other inspections at this facility

  • 1286002 (VAI Fri Nov 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1142420 (VAI Fri May 21 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1084040 (VAI Thu Feb 14 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019222 (VAI Fri May 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 939504 (VAI Fri Aug 21 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
135821 CFR 211.100(b)SOPs not followed / documented
143321 CFR 211.42(c)(10)(iii)Air Supply
145221 CFR 211.113(b)Validation lacking for sterile drug products
358521 CFR 211.110(a)Control procedures to monitor and validate performance
439121 CFR 211.180(e)(2)Items to cover on annual reviews