Korean Manufacturer Warned for GMP, Quality Violations

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.