# FDA 483 - Kurin, Inc. - January 09, 2026

Source: https://www.keypedia.com/records/483/kurin-inc/8f010c54-ba0f-43fb-bbf8-d86b949182e2

> FDA 483 for Kurin, Inc. on January 09, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kurin, Inc.
- Inspection Date: 2026-01-09
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Kurin, Inc. in San Diego, CA, was inspected regarding its manufacturing operations. The inspection revealed significant deficiencies in the firm's complaint handling procedures, specifically concerning the documentation of Medical Device Report (MDR) related complaint investigations. These issues included incomplete product and contact information, and inadequate documentation of corrective actions.

## Related Officers

- [Juanj Wu](https://www.keypedia.com/people/juanj-wu/0d3e8970-b524-49f6-a307-079091b3c91d)

Company: https://www.keypedia.com/companies/kurin-inc/46c14084-98ef-4d56-82f9-cec118e1f1e8

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6