Home / Inspections / 967035

967035

OraLabs, Incorporated — FEI 3001237145

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 18, 2015
Fiscal Year
2016
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))
  • 837917 (NAI Wed Jun 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
197521 CFR 211.182Written records kept in individual logs
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls
435521 CFR 211.165(c)Sampling and testing plans not followed