FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Korean Drugmaker Warned for CGMP Violations

Feb. 12, 2019

The FDA hit Korean OTC drugmaker Soleo with a warning letter after finding significant CGMP violations during an Aug. 6-9, 2018 inspection of its Pyeongtaek-Si, Gyeonggi-do facility.

The firm failed to test incoming raw materials — including APIs and components — used to manufacture an OTC drug product, relying instead on suppliers’ certificates of analysis without ensuring their reliability.

The agency called for the firm to provide the chemical and microbiological quality control specifications it will use to approve each incoming component lot used in manufacturing, as well as a description of at least one identity test for each lot.

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