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1256389

GMP Laboratories of America Inc — FEI 3002710875

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 16, 2024
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Anaheim, CA (United States)

Facility

Other inspections at this facility

  • 1115118 (VAI Tue Jan 14 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1029037 (NAI Thu Sep 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 850294 (VAI Wed Sep 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 774909 (VAI Thu Mar 29 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 639684 (VAI Wed Jan 20 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
203121 CFR 211.194(a)Complete test data included in records