# FDA 483 - Sato Pharmaceutical Co., Ltd. - November 21, 2025

Source: https://www.globalkeysolutions.net/records/483/sato-pharmaceutical-co-ltd/bb84423f-4e53-4ccc-bfc7-84c0590bba5f

> FDA 483 for Sato Pharmaceutical Co., Ltd. on November 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sato Pharmaceutical Co., Ltd.
- Inspection Date: 2025-11-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Sato Pharmaceutical Co., Ltd. in Hachioji, Tokyo, Japan, an OTC drug manufacturer, received a Form 483 with ten observations highlighting significant deficiencies in aseptic processing, quality control, and stability testing. The firm failed to adequately investigate media fill failures and contamination, lacked proper validation for aseptic processes, and had inadequate stability testing programs and laboratory controls, including releasing products without required microbiological testing. Additionally, issues with equipment maintenance and protective apparel were noted, indicating a broad range of quality system breakdowns.

## Related Documents

- [483 - 2018-07-03](https://www.globalkeysolutions.net/records/483/sato-pharmaceutical-co-ltd/98b0da88-cb2a-4120-8872-f3fa327a7216)
- [483 - 2019-10-25](https://www.globalkeysolutions.net/records/483/sato-pharmaceutical-co-ltd/04496436-cb35-4c71-a66f-58ae024f0bc8)
- [483 - 2025-11-13](https://www.globalkeysolutions.net/records/483/sato-pharmaceutical-co-ltd/b93ce6bc-4bf4-47a1-a948-0fb0ed61ef8c)
- [483 - 2018-07-03](https://www.globalkeysolutions.net/records/483/sato-pharmaceutical-co-ltd/bda58c1f-6dfc-4c9c-a3de-38805e3581c6)

## Related Officers

- [Nibin Varghese](https://www.globalkeysolutions.net/people/nibin-varghese/43e17f63-2c1f-4d46-b26f-dc8ac8885438)
- [Consumer Safety Officer ](https://www.globalkeysolutions.net/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

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

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8