Dr. Reddy's API plant stays on probation with an FDA Form 483

Dr. Reddy's says the FDA has issued a Form 483 after an inspection this week at its API plant in Miryalaguda, one of three Dr. Reddy's facilities the FDA cited in a 2015 warning letter.

Dr. Reddy’s had hoped to start moving beyond an FDA warning letter that lambasted three of its India plants for data integrity and other issues in 2015, but those hopes were stymied in the latest inspection of a plant in Miryalaguda.

The drugmaker, in a public filing, said the FDA Tuesday completed an inspection of the API manufacturing plant in Miryalaguda and issued a Form 483 with three observations. It gave no details about the nature of the violations.

In the warning letter, the FDA had cited the plant management for failing to control equipment and records to prevent testing data from being changed or destroyed, which it said employees at that plant had been doing. It also criticized the facility for not determining the root cause of out of spec test results. For one intermediate, 65 batches failed a test for a single impurity over three years.  

Most troubling to the FDA during the three-facility visit was the discovery at Dr. Reddy's plant in Srikakulam of an uncontrolled quality-control lab where records showed the company had been repeatedly testing APIs for impurities, never recording failed tests, and only including those that showed the batches had passed.

The fact that the FDA will not approve new drugs tied to any of the three facilities has recently put in jeopardy Dr. Reddy’s intended launch of a generic of blockbuster cancer drug Gleevec. Because its Oncology Formulation manufacturing facility at Duvvada is one of the three cited facilities, it was unable to produce the drug there. Dr. Reddy’s turned to an outside contractor to help it out but now regulatory problems with its substitute supplier may keep Dr. Reddy’s from getting to market this quarter, it told investors this month.