FDA WARNING_LETTER - Seindni Co., Ltd. - May 26, 2017

The FDA inspected Seindni Co., Ltd.'s drug manufacturing facility in Seoul, Korea, from May 25-26, 2017, identifying significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211). The firm did not respond to the Form FDA 483. Key violations include the failure to establish an adequate quality control unit with the responsibility and authority to approve or reject all components and drug products, including those manufactured by contract companies. Specifically, the firm failed to establish adequate written responsibilities and procedures for its quality control unit (21 CFR 211.22(a) and (d)), lacking procedures for batch release and documentation of product quality. This led to the release of drugs without confirmation of active ingredient identity and strength. The FDA emphasized that Seindni is responsible for drug quality, regardless of contract manufacturing agreements, and that their contract manufacturers were not conforming to CGMP. The letter also highlighted labeling concerns, reminding the firm of its responsibility to comply with all federal law and FDA regulations for OTC drug products, including specific requirements for Drug Facts panels, directions, and warnings for products like sunscreens. Due to these deficiencies, Seindni Co., Ltd. was placed on Import Alert 66-40. The FDA may withhold approval of new applications and refuse admission of products into the U.S. The firm must respond within 15 working days with corrective actions, including written procedures for its quality unit, batch release, and supplier oversight, and is strongly recommended to engage a CGMP consultant.