# FDA 483 - Taisho Pharmaceutical Co., Ltd. - March 25, 2019

Source: https://www.globalkeysolutions.net/records/483/taisho-pharmaceutical-co-ltd/a775bef3-32f7-4fea-9bc0-366c3688398a

> FDA 483 for Taisho Pharmaceutical Co., Ltd. on March 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Taisho Pharmaceutical Co., Ltd.
- Inspection Date: 2019-03-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An inspection of Taisho Pharmaceutical Co., Ltd. in Saitama, Japan, revealed significant deficiencies across its operations. The firm was cited for inadequate laboratory and production controls, including issues with data integrity, validation, and system security. Additionally, batch production and control records were found to be incomplete, and written calibration procedures for instruments and temperature monitoring were deficient.

## Related Officers

- [Compliance Officer](https://www.globalkeysolutions.net/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)

Company: https://www.globalkeysolutions.net/companies/taisho-pharmaceutical-co-ltd/290158c7-6701-466a-98f3-d39da84d4805

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