FDA 483 - Fukuyzu Pharmaceutical Co., Ltd. - January 19, 2024

An FDA inspection conducted from January 15-19, 2024, at Fukuzyu Pharmaceutical Co., Ltd. in Toyama, Japan, identified several significant issues related to its Active Pharmaceutical Ingredient (API) manufacturing processes. The observations indicate a lack of robust quality control and data integrity, which are critical for ensuring product safety and efficacy.

Key violations include the quality unit's failure to conduct thorough investigations into out-of-specification results and critical deviations. For instance, investigations into high Pyrimethamine assay and residual solvent levels lacked scientific justification and adequate follow-up on potential impacts to other batches.

Furthermore, the company's cleaning procedures for shared production equipment were found to be insufficient, with apparent residue and particulates observed. Cleaning validation protocols failed to meet stability acceptance criteria for standard solutions, raising concerns about potential cross-contamination, especially between hazardous and non-hazardous substances.

The inspection also noted incomplete validation of analytical methods, specifically the in-house gas chromatography method used for releasing Pyrimethamine API. Crucially, controls over computerized systems and electronic records in the Quality Control laboratory were inadequate. A single administrator had unlimited ability to modify or delete electronic data, and one system lacked essential data integrity features like forced saving and audit trails, compromising the reliability and security of critical quality data.

Fukuzyu Pharmaceutical Co., Ltd. is expected to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with good manufacturing practices and safeguard product quality.