# FDA 483 - Yakult Honsha Co., Ltd. - November 12, 2026

Source: https://www.globalkeysolutions.net/records/483/yakult-honsha-co-ltd/63e9ede0-1fb7-4b2a-ab2f-0adb0a0c9413

> FDA 483 for Yakult Honsha Co., Ltd. on November 12, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Yakult Honsha Co., Ltd.
- Inspection Date: 2026-11-12
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Yakult Honsha Co., Ltd. in Susono, Japan, an API manufacturer, revealed two significant observations. Issues included inadequate qualification of working standards for in-process and finished product testing, relying on outdated historical data. Additionally, the firm's out-of-specification and deviation investigations lacked proper control over handwritten notes, raising concerns about data integrity and completeness of records.

## Related Officers

- [ Investigator ](https://www.globalkeysolutions.net/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

Company: https://www.globalkeysolutions.net/companies/yakult-honsha-co-ltd/16976651-0a00-4dfe-b25b-408d1caca48d

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