FDA 483 - Avox Systems Inc - February 02, 2024

Avox Systems Inc, a medical device manufacturer in Lancaster, NY, was cited with two observations during an FDA inspection. The inspection revealed issues with the provision of Unique Device Identification (UDI) information for their O2 Pak portable oxygen generator and a lack of validation for a critical manufacturing process. The process validation issue was noted as a repeat observation from a previous inspection.