# FDA 483 - Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. - March 22, 2024

Source: https://www.globalkeysolutions.net/records/483/second-tokushima-factory-otsuka-pharmaceutical-co-ltd/ae73bd67-e93b-48af-8279-d731014ad321

> FDA 483 for Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. on March 22, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
- Inspection Date: 2024-03-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspected Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. in Tokushima, Japan, a manufacturer of drug products and sterile/non-sterile drug substances. The inspection revealed significant deficiencies in equipment cleaning, environmental monitoring for aseptic processing, adherence to sampling plans, raw material testing, and investigation of product discrepancies. These findings indicate a need for improved quality control and manufacturing practices to ensure drug product safety and quality.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

Company: https://www.globalkeysolutions.net/companies/second-tokushima-factory-otsuka-pharmaceutical-co-ltd/d07820ec-a994-41cb-b667-509183a6cc4a

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