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Warning Letter

Case 720690 — FEI 3001237145

Facility

Recent inspections

  • 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))

Action Details

Facility
OraLabs, Incorporated
Date
March 11, 2026
Fiscal Year
2026
Product Type
Drugs
Center
CDER
Location
Parker, CO (United States)