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1024252

PCI San Diego, Inc. — FEI 3004575449

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 6, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
San Diego, CA (United States)

Facility

Other inspections at this facility

  • 1266794 (VAI Fri May 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1218719 (VAI Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1142663 (VAI Tue May 25 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1108335 (VAI Wed Aug 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1078569 (VAI Thu Feb 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
180921 CFR 211.160(a)Following/documenting laboratory controls
181021 CFR 211.160(a)Lab controls established, including changes
430321 CFR 211.67(b)Written procedures fail to include