# FDA 483 - Nissui Corporation - November 11, 2022

Source: https://www.keypedia.com/records/483/nissui-corporation/2f7b408e-d24a-470b-9cbd-1fd1c992acb1

> FDA 483 for Nissui Corporation on November 11, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nissui Corporation
- Inspection Date: 2022-11-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Nippon Suisan Kaisha, Ltd. Kashima, a manufacturer of active pharmaceutical ingredients, revealed significant deficiencies. Observations included inadequate laboratory controls, specifically regarding data integrity and system access, and insufficient equipment cleaning procedures. Additionally, master production and control records were found to be incomplete, lacking justifications for yield variations and proper deviation instructions.

## Related Officers

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

Company: https://www.keypedia.com/companies/nissui-corporation/f96bdce1-8d8d-46ca-bfa6-1d572c482647

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