# FDA 483 - Machida Endoscope Co., Ltd. - December 07, 2023

Source: https://www.keypedia.com/records/483/machida-endoscope-co-ltd/07d2dee0-46ea-4887-aff8-4e33f32d15be

> FDA 483 for Machida Endoscope Co., Ltd. on December 07, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Machida Endoscope Co., Ltd.
- Inspection Date: 2023-12-07
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Machida Endoscope Co., Ltd. in Abiko, Chiba, Japan, was inspected by the FDA from December 4-7, 2023. The inspection revealed that the firm failed to adequately establish procedures for the review and disposition of nonconforming products. Specifically, the firm did not document the justification for the use of a nonconforming Flexible Nasopharyngo Laryngoscope.

## Related Officers

- [Marlo-Ian M. Alintanahin](https://www.keypedia.com/people/marlo-ian-m-alintanahin/a37da927-b369-4753-b275-41743556f25e)

Company: https://www.keypedia.com/companies/machida-endoscope-co-ltd/a40c9c5c-d7f3-4685-98c7-4ac681a1539f

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