# FDA 483 - Sato Pharmaceutical Co., Ltd. - October 25, 2019

Source: https://www.keypedia.com/records/483/sato-pharmaceutical-co-ltd/04496436-cb35-4c71-a66f-58ae024f0bc8

> FDA 483 for Sato Pharmaceutical Co., Ltd. on October 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sato Pharmaceutical Co., Ltd.
- Inspection Date: 2019-10-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Sato Pharmaceutical Co., Ltd. in Hachioji, Tokyo, Japan, was inspected by the FDA from October 17-25, 2019, revealing significant deficiencies in equipment cleaning, data integrity, quality control, and warehouse management. The inspection found issues including inadequate cleaning validation for production line hoses, lack of control over electronic records and alarm histories, and insufficient procedures for warehousing and batch record documentation. These findings indicate a general lack of robust quality systems and controls for drug products distributed to the United States.

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## Related Officers

- [Jason R. Caballero](https://www.keypedia.com/people/jason-r-caballero/c2c8d281-0d02-459f-9541-bc04cb6d0a59)

Company: https://www.keypedia.com/companies/sato-pharmaceutical-co-ltd/5e274c7f-ada5-44d9-8c9b-068c7392b4ea

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