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1114784

OraLabs, Incorporated — FEI 3001237145

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 10, 2020
Fiscal Year
2020
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))
  • 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
141321 CFR 211.42(c)(5)Mfg / Processing Operations Area
356521 CFR 211.58Buildings not maintained in good state of repair
360321 CFR 211.160(b)Scientifically sound laboratory controls
430221 CFR 211.56(b)Written sanitation procedures not followed