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# Taenaka Kogyo Inspection Cites 4 Observations
- URL: https://www.fdaweb.com/taenaka-kogyo-inspection-cites-4-observations/
- Published: 2024-09-06T12:00:00.000Z
- Updated: 2026-09-14T14:40:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157730

An April inspection of Taenaka Kogyo (Mobara, Chiba, Japan) has resulted in a four-observation [Form FDA-483](https://www.fda.gov/media/181559/download?ref=fdaweb.com) that cites significant GMP violations. For example, the agency says the firm’s training was not regularly conducted by qualified individuals, and it did not cover the operations the employees performed. The firm’s ventilation systems were also found to be deficient and not adequately designed, the inspection report says. Additionally, FDA found that testing designed to ensure that the company’s active pharmaceutical ingredients’ specifications for microbiological purity and appropriate action limits for total microbial counts and objectionable organisms are met was not conducted in a way that ensured the validity of results.