# FDA 483 - Konan Medical Inc. - November 30, 2023

Source: https://www.keypedia.com/records/483/konan-medical-inc/c27a8853-574d-4326-afda-846155e8f239

> FDA 483 for Konan Medical Inc. on November 30, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Konan Medical Inc.
- Inspection Date: 2023-11-30
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Konan Medical Inc., a manufacturer in Nishinomiya, Japan, was inspected by the FDA from November 27-30, 2023. The inspection resulted in one observation related to the firm's corrective and preventive action (CAPA) system. Specifically, the firm failed to document an effectiveness and verification plan for proposed corrective actions.

## 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/konan-medical-inc/7e92f3f1-73c4-40ef-94a2-c4c60031c634

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