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OraLabs, Inc. Warning Letter Details
Warning Letter
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Overview
Violations
Related Form 483s
6
Related Inspections
9
OraLabs, Inc.
OraLabs, Inc., 18685 East Plaza Drive Parker , CO 80134-9061 United States
Issue Date
March 11, 2026
FEI Number
3001237145
Violations
2
Country
United States
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Subject
CGMP/Finished Pharmaceuticals/Adulterated
OraLabs, Inc. FDA Warning Letter, March 11, 2026