FDA 483 - Carrio Cabling Corporation - October 27, 2023

Carrio Cabling Corporation, a medical device manufacturer in Colorado Springs, CO, was cited with five observations during an FDA inspection. The firm demonstrated significant deficiencies across its quality system, including inadequate complaint handling, unvalidated software, poorly maintained device history records, a lack of risk analysis, and insufficient control over nonconforming products. These issues indicate a systemic failure to establish and follow critical quality system procedures.