FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Korean Manufacturer Warned for Adulterated Products

Jan. 8, 2018
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The FDA issued a warning letter to Korean drug manufacturer Amaros, citing significant quality and GMP violations.

During an inspection of the firm’s Seongnam, South Korea facility in May, inspectors observed the facility did not have a quality unit with the authority and responsibility to approve or reject items such as drug components, containers, labels and drug products. The facility also lacked written procedures for numerous functions, including complaints, batch releases, supplier qualifications and deviations.

The company, in conjunction with contract manufacturers, released drug products that were not tested for identity and strength.

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