FDA 483 - Shanghai Kyowa Amino Acid Co., Ltd. - December 15, 2023

During an inspection conducted from December 11-15, 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Shanghai Kyowa Amino Acid Co., Ltd., an API manufacturing facility located in Shanghai, China. The inspection identified a significant issue related to the firm's adherence to its written production and process control procedures. The primary observation noted that the company failed to initiate proper deviation investigations. Specifically, instances of "corrosion" and "floating rust" were observed in a processing tank (number (b)(4)-30) on July 26, 2023, and again on November 21, 2023. Despite these findings being recorded in maintenance logs, the firm did not open formal deviation investigations as required by its own Standard Operating Procedure (SOP ZGB-AM-013-17). This SOP explicitly categorizes events such as "Risk of foreign matters in production" and "rust caused by equipment corrosion" as unplanned deviations necessitating investigation. Notably, this observation was cited as a repeat finding from previous inspections, indicating a recurring compliance challenge. This Form 483 serves as a formal communication of inspectional observations. While it does not represent a final determination of compliance, Shanghai Kyowa Amino Acid Co., Ltd. is expected to promptly address these deficiencies by implementing effective corrective actions to ensure adherence to Good Manufacturing Practices and prevent future recurrences.