FDA 483 - Hakko Co., Ltd. - May 25, 2023

Hakko Co., Ltd., a medical device manufacturer in Chikuma, Nagano, Japan, received a Form FDA 483 with five observations during an inspection. The firm was cited for significant deficiencies in its quality system, including undeveloped production processes, unvalidated critical manufacturing steps, inadequate in-process product acceptance procedures, and issues with device history records and sampling plans. These findings indicate a lack of robust controls over their medical device manufacturing operations.