FDA 483 - Taenaka Kogyo Co., Ltd. - April 12, 2024

During an FDA inspection conducted from April 8 to April 12, 2024, at Taenaka Kogyo Co., Ltd., an active pharmaceutical ingredient manufacturer in Mobara, Chiba, Japan, several significant observations were noted, indicating deviations from current good manufacturing practices. The inspection revealed four primary areas of concern. Firstly, the company's employee training was found to be insufficient, specifically lacking proper assessment for operators performing visual inspections of finished drug substances, potentially compromising contaminant detection. Secondly, ventilation systems in production suites were inadequately designed and monitored. An observed drop in critical air pressure differentials and the absence of alarm systems on monitoring devices presented a contamination risk to in-process materials. Thirdly, temperature-controlled storage chambers, used for stability samples and microbiological incubators, lacked sufficient monitoring to ensure timely detection and response to temperature excursions, particularly outside standard office hours. Finally, the validity of microbiological purity testing for API release was questioned due to inadequate growth promotion testing of all received lots of growth media plates. These observations require Taenaka Kogyo Co., Ltd. to implement comprehensive corrective actions to address the identified deficiencies in training, environmental control, storage monitoring, and quality control testing to ensure product quality and regulatory compliance.