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1046565

Pacific BioLabs, Inc. — FEI 2914117

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 19, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hercules, CA (United States)

Facility

Other inspections at this facility

  • 1277213 (VAI Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1206864 (VAI Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 851917 (VAI Wed Oct 30 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 694550 (NAI Tue Oct 19 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 663601 (NAI Mon May 24 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
181021 CFR 211.160(a)Lab controls established, including changes
435321 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
440221 CFR 211.192Written record of investigation incomplete