Kurin, Inc.January 9, 2026

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

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Record Details

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.

Company: Kurin, Inc.
Inspection Date: January 9, 2026
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
Person: Juanj Wu

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ID · 8f010c54-ba0f-43fb-bbf8-d86b949182e2