# FDA 483 - Fukuzyu Pharmaceutical Co., Ltd. - January 19, 2024

Source: https://www.keypedia.com/records/483/fukuzyu-pharmaceutical-co-ltd/66552528-7f7e-40bd-b48e-8d2fbc441945

> FDA 483 for Fukuzyu Pharmaceutical Co., Ltd. on January 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fukuzyu Pharmaceutical Co., Ltd.
- Inspection Date: 2024-01-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Fukuzyu Pharmaceutical Co., Ltd. in Toyama, Japan, an API manufacturer, was cited for four significant observations during an FDA inspection. The firm failed to conduct thorough investigations for out-of-specification results and critical deviations, and exhibited inadequate cleaning and maintenance of shared production equipment. Additionally, the inspection revealed incomplete validation of analytical methods and insufficient control over computerized systems and electronic records in the QC laboratory, indicating serious deficiencies in quality control and data integrity.

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## Related Officers

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Company: https://www.keypedia.com/companies/fukuzyu-pharmaceutical-co-ltd/3877ef0e-8f5d-4826-a235-7e04748254de

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1