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1252504

Oral Biotech, LLC — FEI 3003422682

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 24, 2024
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Albany, OR (United States)

Facility

Other inspections at this facility

  • 1181597 (NAI Tue Sep 27 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056597 (VAI Fri Jun 22 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 921337 (VAI Thu Apr 02 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 746170 (NAI Tue Aug 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
117721 CFR 211.63Equipment Design, Size and Location
358521 CFR 211.110(a)Control procedures to monitor and validate performance