# FDA 483 - TOYO Pharmaceutical Co., Ltd. - June 16, 2023

Source: https://www.keypedia.com/records/483/toyo-pharmaceutical-co-ltd/599cc02e-c264-4290-8e68-dd4bbaaa843e

> FDA 483 for TOYO Pharmaceutical Co., Ltd. on June 16, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TOYO Pharmaceutical Co., Ltd.
- Inspection Date: 2023-06-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: TOYO Pharmaceutical Co., Ltd., a contract manufacturer in Osaka, Japan, was cited for significant deficiencies during an FDA inspection. Observations included failures to document deviations from production and process control procedures, such as out-of-specification results and overdue maintenance, and a lack of documented training for employees performing critical visual inspections of drug products. These issues indicate a breakdown in quality control and personnel qualification processes.

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

Company: https://www.keypedia.com/companies/toyo-pharmaceutical-co-ltd/21837e65-0d4e-4e06-becd-fd959cccc990

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