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

Source: https://www.globalkeysolutions.net/records/483/hakko-co-ltd/7602a6c8-4dbb-4b03-b080-5911d10b2b01

> FDA 483 for Hakko Co., Ltd. on May 25, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hakko Co., Ltd.
- Inspection Date: 2023-05-25
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Thai T. Duong](https://www.globalkeysolutions.net/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.globalkeysolutions.net/companies/hakko-co-ltd/a294e449-9394-4e19-b95f-f0c8f058da22

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd