# FDA 483 - Nissui Corporation - December 15, 2023

Source: https://www.keypedia.com/records/483/nissui-corporation/34258a92-1db6-44ed-afa2-b4df7939b094

> FDA 483 for Nissui Corporation on December 15, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nissui Corporation
- Inspection Date: 2023-12-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Nissui Corporation in Tsukuba, Japan, was inspected by the FDA from December 11-15, 2023, revealing significant deficiencies. The firm failed to follow its written stability testing program, resulting in active pharmaceutical ingredient samples being stored under out-of-specification humidity conditions. Additionally, procedures for equipment cleaning and maintenance were found to be deficient, lacking proper schedules and scientific justification for not cleaning certain tanks.

## Related Officers

- [Investigator](https://www.keypedia.com/people/jolanna-a-norton/5501fea4-4bfd-434c-b2aa-fcf94444f684)

Company: https://www.keypedia.com/companies/nissui-corporation/5c10b1f1-5ac4-498a-b5d4-371a8f48d08e

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