# FDA 483 - Hamari PFST, Ltd. - November 10, 2023

Source: https://www.keypedia.com/records/483/hamari-pfst-ltd/3c210069-140b-4b1e-9ed4-25505f04621b

> FDA 483 for Hamari PFST, Ltd. on November 10, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hamari PFST, Ltd.
- Inspection Date: 2023-11-10
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Hamari PFST, Ltd., an API manufacturer in Yonezawa, Japan, was cited for two observations during an FDA inspection. The inspection revealed deficiencies in establishing written procedures for cleaning equipment and ensuring timely documentation of cleaning activities. These issues indicate a lack of adequate control over manufacturing processes and record-keeping practices.

## Related Officers

- [Michele Gottshall](https://www.keypedia.com/people/michele-gottshall/f12dcaf7-8958-4591-88bb-f9746796b934)

Company: https://www.keypedia.com/companies/hamari-pfst-ltd/17548bf6-b8d5-4469-be75-78ca6f0f7bd5

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