# FDA 483 - Morishita Jintan Co., Ltd. - May 19, 2023

Source: https://www.globalkeysolutions.net/records/483/morishita-jintan-co-ltd/8acbeca2-3bfe-4a51-8be2-98ba099698f6

> FDA 483 for Morishita Jintan Co., Ltd. on May 19, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Morishita Jintan Co., Ltd.
- Inspection Date: 2023-05-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Morishita Jintan Co., Ltd., a homeopathic drug manufacturer in Tsukumi-Gun, Shiga, Japan, revealed significant deficiencies across production, laboratory controls, and stability testing. The firm failed to validate manufacturing processes and an ERP software system, lacked scientifically sound microbial specifications for a drug product, and conducted stability studies using an inappropriate container-closure system. These issues indicate a lack of adequate controls to assure drug product quality and purity.

## Related Officers

- [Drug Specialist  / Drug Investigator](https://www.globalkeysolutions.net/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

Company: https://www.globalkeysolutions.net/companies/morishita-jintan-co-ltd/60905237-f2c7-470f-b321-b46547c1f7df

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