FDA issues rule violation warning to It’S Hanbul and Cosmecca

FDA issues rule violation warning to It’S Hanbul and Cosmecca

The Food and Drug Administration has issued a warning to Korean cosmetics makers  It’S Hanbul Cosmetics and Cosmecca for ‘significant violations of current good manufacturing practice.’

Both companies were pulled up for violating good manufacturing practice (CGMP) regulations, with the FDA stating It’S Hanbul has continued to market non-compliant products following a visit to its Chuncheonbuk-do manufacturing facilities in November. This visit found the company to have four specific violations, one of which being that the company failed to provide complete laboratory records for all the necessary tests, with other violations including incomplete records and inadequate testing programs.

The FDA stated in the warning letter, “Your response is inadequate because it did not provide sufficient evidence of corrective actions to bring your operations into compliance with CGMP. Your response did not include any interim measures to be taken until you complete all proposed corrective actions. Furthermore, your response did not address the effect these violations may have had on OTC drug products within expiry and currently on the U.S. market.”

Cosmecca meanwhile received an FDA letter regarding its pharmaceutical products, which stated, “Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.”

Should the companies fail to address the violations, the FDA has issued a warning that it may refuse to admit articles manufactured in the plant into the US.

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