# FDA 483 - Sato Pharmaceutical Co., Ltd. - July 03, 2018

Source: https://www.keypedia.com/records/483/sato-pharmaceutical-co-ltd/bda58c1f-6dfc-4c9c-a3de-38805e3581c6

> FDA 483 for Sato Pharmaceutical Co., Ltd. on July 03, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sato Pharmaceutical Co., Ltd.
- Inspection Date: 2018-07-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Sato Pharmaceutical Company Limited in Hachioji, Tokyo, was cited for significant deficiencies across its drug manufacturing operations. Observations included failures in quality control unit procedures, inadequate environmental monitoring in aseptic processing areas, and a lack of scientifically sound laboratory controls for container closure integrity. Additionally, the firm failed to maintain backup files for critical laboratory data, indicating systemic data integrity concerns.

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## Related Officers

- [Director of Inspection Readiness](https://www.keypedia.com/people/bonita-s-chester/cc6ce6f4-bb5c-452a-820c-3339361bc8b2)
- [Stephen M. Wennerstrom](https://www.keypedia.com/people/stephen-m-wennerstrom/f8a2c1aa-bf6f-4caf-85ea-46fc787308ea)

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