FDA 483 - AustarPharma, LLC - April 05, 2023

Austarpharma LLC, a drug manufacturer in Edison, NJ, was inspected by the FDA from March 22 to April 5, 2023. The inspection revealed significant deficiencies in personnel training for critical laboratory operations and a failure to perform required preventative maintenance on analytical instruments. These issues indicate a lack of adequate quality control and could impact the reliability of product testing.