FDA 483 - Arklign Laboratories, Inc. - October 28, 2025

Arklign Laboratories, Inc., a repackager/relabeler of dental restorations in San Jose, CA, was cited for significant deficiencies across its quality system. The inspection revealed a lack of established procedures for critical processes like CAPA, complaint handling, MDR, quality plans, and audits, alongside failures in UDI labeling and database registration. These findings indicate a fundamental absence of a compliant quality management system.