FDA 483 - Andhra Organics Limited - November 01, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 02e8e690-0582-4c8a-8549-45ec0b19fc6a