Avioq, Inc. – FDA 483, May 14, 2026

Avioq, Inc. in Durham, NC, received an FDA Form 483 citing inadequate maintenance of records for risk management activities during product realization. The inspection revealed deficiencies in the firm's risk assessments for several non-conformance reports, including issues with incorrect expiration dates, deviations in lysate usage, and the use of non-conforming components. These assessments were found to lack specific data and failed to properly categorize risks according to the firm's own standard operating procedures.