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1142420

Alliance Medical Products, Inc. — FEI 2027189

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 21, 2021
Fiscal Year
2021
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))
  • 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
126121 CFR 211.68(a)Written calibration / inspection records not kept
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
202721 CFR 211.192Investigations of discrepancies, failures