FDA 483 - Avioq, Inc. - February 27, 2019

Avioq, Inc., an in-vitro diagnostic manufacturer in Research Triangle Park, Durham, NC, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately investigate and conclude numerous product complaints, implement changes with proper validation, and adhere to or maintain complete standard operating procedures and quality agreements. Additionally, the inspection revealed issues with the qualification and verification of incoming materials.