FDA 483 - Amphenol DC Electronics Inc. - October 23, 2025

An FDA inspection conducted from October 20-23, 2025, at Amphenol DC Electronics Inc., a contract manufacturer of medical devices, identified several deficiencies impacting their quality system. The inspection, carried out under the Federal Food, Drug, and Cosmetic Act, highlighted three significant observations. Firstly, the company lacked documented process validation for critical crimping machines used in producing Class II and Class III medical device cables, raising concerns about consistent product quality. Secondly, device history records for Class II medical devices were incomplete, failing to include or reference the unique device identifier (UDI) or primary product labels, which is essential for traceability and regulatory compliance. Lastly, Amphenol DC Electronics Inc. exhibited inadequate complaint handling procedures. Specifically, the firm did not consistently complete Failure/Root Cause Analyses within the established timelines outlined in their own RMA process, indicating a breakdown in their complaint evaluation system. In response to these findings, the company indicated a commitment to correcting each of the identified observations, emphasizing the need for robust quality systems to ensure product safety and compliance with FDA regulations.