FDA 483 - Avox Systems Inc - February 02, 2024

During an FDA inspection conducted from January 29 to February 2, 2024, Avox Systems Inc. in Lancaster, NY, a medical device manufacturer, received a Form FDA 483 citing two significant observations related to their quality system. The first observation highlighted a deficiency in the company's Unique Device Identification (UDI) compliance. Specifically, information required for the O₂ Pak portable oxygen generator was not accurately provided in the Global Unique Device Identification Database (GUDID). This issue extended to the device label, as well as the company's labeling procedures and Device History Records, where essential UDI data was missing. The second, and repeat, observation concerned the validation of a critical manufacturing process. The process used to attach the head assembly on a chemical oxygen generator, a component of the O₂PAK Portable Oxygen Generator, had not been properly validated according to established procedures. This same deficiency was previously noted during an FDA inspection in August 2021, indicating a persistent non-conformance. These observations suggest a need for Avox Systems Inc. to enhance its adherence to medical device quality system regulations, particularly concerning device traceability and process control. The company indicated it has promised to correct both observations, and is responsible for thorough internal self-audits to ensure full compliance.