FDA 483 - Kinkando Co., Ltd. - May 09, 2025

Kinkando Co., Ltd. in Honjo, Japan, was inspected and cited for significant deficiencies across multiple areas of its drug manufacturing operations. Observations included inadequate controls for microbial contamination, insufficient laboratory controls for stability testing and data integrity, and a failure to follow written production and process control procedures. These issues indicate a lack of robust quality systems and could impact drug product quality and purity.