# FDA 483 - Ono Pharmaceutical Co., Ltd. - December 17, 2018

Source: https://www.globalkeysolutions.net/records/483/ono-pharmaceutical-co-ltd/6db3aa1e-61da-4d88-8ffa-b694cec54584

> FDA 483 for Ono Pharmaceutical Co., Ltd. on December 17, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ono Pharmaceutical Co., Ltd.
- Inspection Date: 2018-12-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Ono Pharmaceutical Co., Ltd in Fujinomia-shi, Japan, revealed significant deficiencies in their drug manufacturing operations. Observations included inadequate equipment cleaning procedures, a lack of scientifically sound laboratory test procedures for drug product conformity, and failures within the quality control unit to properly review data. These issues suggest a need for improved adherence to Good Manufacturing Practices to ensure product quality and purity.

## Related Officers

- [Dennis Castellops](https://www.globalkeysolutions.net/people/dennis-castellops/e3936f53-2a46-4b48-983f-79a78bba432a)

Company: https://www.globalkeysolutions.net/companies/ono-pharmaceutical-co-ltd/55f1bf6b-b85e-4cfd-8b11-64980dbc175f

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