Aurobindo Plant Hit With Lengthy 483

The FDA issued a 10-observation Form 483 to Aurobindo’s Telangana, India, plant after a November visit, outlining several violations of current good manufacturing practices (cGMP).

According to an FDA investigator, the generic drug manufacturer and maker of active pharmaceutical ingredients (API) didn’t properly follow up on customer complaints, laboratory control mechanisms weren’t appropriate, and failed to make sure raw materials and APIs adhere to standards.

According to an FDA investigator, Aurobindo didn’t properly follow up on customer complaints, laboratory control mechanisms weren’t appropriate and failed to make sure raw materials and APIs adhere to standards.

This is the third Aurobindo plant to receive a damning inspection report from the FDA in the past year and the second 483 in just over three years for the company’s Telangana plant.