FDA 483 - Daito Pharmaceutical Co., Ltd. - December 19, 2023

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from December 11 to December 19, 2023, Daito Pharmaceutical Co., Ltd., a manufacturer located in Toyama-City, Japan, received a Form FDA 483 detailing two significant observations. These observations highlight areas where the firm's practices do not meet regulatory expectations for drug manufacturing. The first observation concerned the absence of adequate written procedures for the cleaning and maintenance of equipment. Specifically, the company's existing cross-contamination monitoring program was found insufficient as it failed to include monitoring of production suites, manufacturing equipment, and personnel. This issue is particularly relevant given that the firm produces several drugs, including one intended for the U.S. market. The second observation noted deficiencies in the firm's laboratory controls. It was observed that Daito Pharmaceutical Co., Ltd. uses a non-pharmacopeia standard for testing raw materials, and this standard had not been properly qualified against the U.S. Pharmacopeia (USP) reference standard. This lapse indicates a potential risk to assuring that drug products conform to appropriate standards of identity, strength, quality, and purity. As per FDA regulations, Daito Pharmaceutical Co., Ltd. is expected to address these observations by implementing corrective actions and submitting a response to the FDA to demonstrate compliance and ensure product quality and safety for consumers.