FDA 483 - Robbins Instruments, LLC - May 31, 2024

Robbins Instruments, LLC, an initial importer and assembler of the Dermo-Jet Needleless Injector, was cited for significant quality system deficiencies during a March 2024 inspection. The firm lacked validated sterilization processes, proper design controls, and a functional complaint handling system, leading to uninvestigated device failures and inadequate MDR reporting. Overall, the inspection revealed a pervasive lack of established procedures and documentation across critical quality system elements, including device history records, acceptance activities, servicing, labeling, management review, and quality audits.