# FDA 483 - Katayama Seiyakusyo Co. Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/katayama-seiyakusyo-co-ltd/29b899a2-196d-4fd5-b09d-c72d5e9cfc53

> FDA 483 for Katayama Seiyakusyo Co. Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Katayama Seiyakusyo Co. Ltd.
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of KATAYAMA SEIYAKUSYO CO., LTD. in Hirakata, Osaka, Japan, an intermediate API and API manufacturer, revealed significant deficiencies across its quality systems, equipment, facilities, production, and laboratory controls. Observations included inadequate water monitoring, incomplete investigation reports, lack of cleaning validation, unverified balances, unsanitary storage conditions, unclear batch record instructions, and compromised sample integrity. These findings indicate a failure to ensure the quality and purity of manufactured products.

## Related Officers

- [Investigator](https://www.keypedia.com/people/noreen-muniz/0bb20d12-62ad-42aa-8b0a-c44b339d413f)

Company: https://www.keypedia.com/companies/katayama-seiyakusyo-co-ltd/b44a0d93-7114-4629-96f0-ef14f4202a13

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3