Another Indian drug manufacturer hit with a Form 483 over recent observations
Several Indian drug manufacturers have been put under a microscope by the FDA, as major generics manufacturers have been hit in recent months by Form 483s. And now Dr. Reddy’s Laboratories is the latest to get the slap.
According to the Indian business news site Business Standard, Dr. Reddy’s Laboratories was served a Form 483. The form highlighted two observations after inspecting its manufacturing facility located at Srikakulam, India, a city in the east.
The regulatory filing noted that the facility in question is Dr. Reddy’s formulation facility dubbed FTO 11. However, the specifics of what was observed have not been released. The inspection itself was conducted from June 30 to July 7 of this year.
Dr. Reddy’s Laboratories site in Srikakulam has not escaped the gaze of the FDA in the past. The site was hit with 483’s in 2014 and 2017, with the company receiving 14 prior Form 483s since 2017.
The result of the 483 is not great for the investment line for Dr. Reddy’s as they have seen their stock price drop 14% since January.
However, Dr. Reddy’s is not the only Indian company that is managing to rack up a high number of inspections and observations. Sun Pharma’s plant in Halol, India received several stark observations from the FDA including deficient procedures to prevent microbiological contamination of drugs, as well as deficient aseptic processing areas for monitoring environmental conditions and equipment and utensils not being cleaned or sanitized at appropriate intervals, among others.
Aurobindo Pharma, which has stacked up 15 483’s since 2016, was recently sent a warning letter from the Securities Exchange Board of India, SEBI, over disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the FDA between 2019 and 2022.
Aurobindo also had to close its site in New Jersey in March.