# FDA 483 - Shiono Finesse Ltd. - June 08, 2018

Source: https://www.globalkeysolutions.net/records/483/shiono-finesse-ltd/692fa5aa-e5dc-4ed3-a475-2966cf6c9e60

> FDA 483 for Shiono Finesse Ltd. on June 08, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shiono Finesse Ltd.
- Inspection Date: 2018-06-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Shiono Finesse, Ltd. in Sakai, Fukui, an API manufacturer, was cited with eight observations during an FDA inspection. The observations highlight significant deficiencies in data integrity, equipment cleaning, maintenance programs, process validation, raw material sampling, change control, supplier qualification, and reserve sample management. These issues indicate a lack of robust quality control and adherence to good manufacturing practices.

## Related Documents

- [483 - 2018-06-08](https://www.globalkeysolutions.net/records/483/shiono-finesse-ltd/bd070728-6445-4c3d-bf44-77d9e12477b4)

## Related Officers

- [Compliance Officer](https://www.globalkeysolutions.net/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)

Company: https://www.globalkeysolutions.net/companies/shiono-finesse-ltd/03229f45-5bb7-4a9e-a260-2330a6104c93

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