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FDA Warns Korean Firm Soleo For GMP Violations, Unapproved Shampoo Drug

Executive Summary

Soleo’s Marum GENtLE THERAPY Shampoo, marketed as an anti-dandruff and hair-growth treatment, is an unapproved new drug, according to FDA. The agency’s warning letter, citing “significant” CGMP violations, follows an August 2018 inspection of the firm’s Pyeongtaek-based facility.


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