FDA To Hanbul Cosmetics: You’re Marketing Noncompliant Drugs

The agency’s warning letter cites the Korean firm, whose offering includes sunscreen and skin-whitening products, for violations of drug CGMP regulations. Problems identified during a recent inspection include microbiological testing failures and questions about equipment quality.

Vintage inscription made by old typewriter, warning

Korean firm It’S Hanbul Co., Ltd., dba Hanbul Cosmetics, must report back to FDA about corrective measures it’s taken since a late 2017 inspection that found “significant” violations of current good manufacturing practices (CGMP) regulations for finished pharmaceuticals.

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