# FDA 483 - Tosoh Bioscience Inc - October 16, 2018

Source: https://www.globalkeysolutions.net/records/483/tosoh-bioscience-inc/d7cf3a9a-ba0e-4b96-8c6b-4d9f81fbade5

> FDA 483 for Tosoh Bioscience Inc on October 16, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tosoh Bioscience Inc
- Inspection Date: 2018-10-16
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Tosoh Bioscience Inc. in Grove City, OH, a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate procedures for corrective and preventive actions, control of nonconforming product, servicing activities, and process validation. These issues indicate a lack of adherence to established quality management principles.

## Related Officers

- [Medical Device Specialist](https://www.globalkeysolutions.net/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)

Company: https://www.globalkeysolutions.net/companies/tosoh-bioscience-inc/329a224c-abeb-4040-9fd6-0aa435bccec2

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22