483
Hakko Co., Ltd.FDA 483 - Hakko Co., Ltd. - May 25, 2023
Record Details
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.
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ID · 7602a6c8-4dbb-4b03-b080-5911d10b2b01