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1284290

OraLabs, Incorporated — FEI 3001237145

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 2, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Parker, CO (United States)

Facility

Other inspections at this facility

  • 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))
  • 837917 (NAI Wed Jun 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
180921 CFR 211.160(a)Following/documenting laboratory controls
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance