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

Taenaka Kogyo Co., Ltd., an active pharmaceutical ingredient manufacturer in Mobara, Chiba, Japan, was cited for significant deficiencies during an FDA inspection. Observations included inadequate employee training and assessment for visual inspection, poorly designed ventilation systems leading to contamination risks, and insufficient monitoring of temperature-controlled storage. Additionally, the firm's microbiological purity testing was found to be invalid due to inadequate growth promotion testing of media plates.