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1286002

Alliance Medical Products, Inc. — FEI 2027189

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 7, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Irvine, CA (United States)

Facility

Other inspections at this facility

  • 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))
  • 889128 (NAI Fri Jul 25 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
143521 CFR 211.42(c)(10)(v)Cleaning System
145221 CFR 211.113(b)Validation lacking for sterile drug products
202821 CFR 211.192Extent of discrepancy, failure investigations
360321 CFR 211.160(b)Scientifically sound laboratory controls