- Dr. Reddy's Laboratories, one of India's largest drugmakers, has hit a snag in its efforts to resolve GMP violations at its Miryalaguda plant, disclosing on Feb. 21 that a re-inspection audit of the facility resulted in a Form 483 with three observations which may constitute further compliance shortfalls.
- The large Indian drugmaker has been working to get its manufacturing facilities up to code after a Nov. 2015 warning letter from the Food and Drug Administration flagged a number of concerns at three separate plants, including Miryalaguda.
- Other India-based drug manufacturers, most notably Sun Pharma, have struggled to clear FDA warning letters, which have been issued at a much faster clip over the past several years. The stepped-up oversight has impacted even the likes of Pfizer, which temporarily closed a facility in India after FDA inspections in Aug. 2016.
The Form 483 is not yet public and Dr. Reddy's did not elaborate on the nature of the FDA’s "three observations." But the letter is still a blow to the India-based company after a nearly-two year back and forth with the U.S. agency over the Miryalaguda plant.
In the FDA’s original Nov. 2015 warning letter, agency inspectors cited Dr. Reddy's for failing to properly investigate batch failings or follow procedures designed to prevent contamination.
Among its findings, the FDA said the Miryalaguda facility did not properly document why filled vials were rejected, nor did it properly train operators to visually inspect drugs moving through production.
The FDA issued the warning letter because Dr. Reddy's responses to the initial inspections were insufficient to fully meet the regulator's concerns. Dr. Reddy's said it had corrected conditions at the plant a year later and requested a re-inspection of the site, which has now resulted in another Form 483.