The FDA issued a warning to a Korean drugmaker for significant current good manufacturing practice violations and the lack of an adequate quality control unit.
The company, Seindni, did not respond to a Form 483 issued after a May 25-26 inspection of its Seoul facility, which uncovered numerous issues, including the manufacturing of adulterated drug products and a lack of documentation for product quality and batch manufacturing.
The agency also noted the facility lacked acceptable written procedures and responsibilities for the quality unit.
In addition, the company used contract manufacturers in the production of finished drug products but the drugs were not tested for strength of ingredients or identity.
Labeling concerns were also an issue for the company, whose OTC medical sunscreen products lacked an FDA-approved drug facts panel, directions and warnings.