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678668

OraLabs, Incorporated — FEI 3001237145

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 11, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Parker, CO (United States)

Facility

Other inspections at this facility

  • 1284290 (OAI Thu Oct 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1114784 (VAI Fri Jan 10 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1090928 (VAI Tue May 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061733 (VAI Fri Jul 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 967035 (VAI Fri Dec 18 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
113321 CFR 211.25(a)GMP Training Frequency
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
180921 CFR 211.160(a)Following/documenting laboratory controls
188321 CFR 211.165(a)Testing and release for distribution
200921 CFR 211.188Prepared for each batch, include complete information
202721 CFR 211.192Investigations of discrepancies, failures
220321 CFR 211.186(b)(7)Theoretical Yield and Percentages
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
358521 CFR 211.110(a)Control procedures to monitor and validate performance
363921 CFR 211.204Returned drug procedures in writing and followed
438721 CFR 211.198(a)Reporting of adverse drug experience to FDA