FDA 483 - Andhra Organics Limited - November 01, 2019

Andhra Organics Limited, a drug substance manufacturer in Payakaraopeta, India, was inspected by the FDA from October 28 to November 1, 2019. The inspection revealed that the Quality Control Unit failed to establish scientifically sound analytical test procedures, specifically lacking daily performance qualification for a titrator used in assay testing of finished drug substance. This deficiency led to equipment malfunctions and a failure to obtain assay results without identified root causes.