- More work lies ahead for Dr. Reddy's Laboratories as the Indian drugmaker tries to convince U.S. regulators that one of its manufacturing plants is up to snuff.
- The Food and Drug Administration on Tuesday completed an audit of the Srikakulam-based production site for active pharmaceutical ingredient (API), flagging two observations in which the site didn't meet regulatory standards.
- As a result, Dr. Reddy's received a Form 483, which signals possible violations of the U.S. Food, Drug and Cosmetic Act and usually presages an eventual warning letter. The company said in an April 4 letter to stock exchanges it is addressing those issues raised by the FDA.
This is yet another setback for Dr. Reddy's in its quest to prove the quality and safety of the medicines it makes — a goal that has been difficult to achieve for many Indian manufacturers. In late February, the company disclosed a different facility located in the city of Miryalguda also received a Form 483 for three observations.
The FDA had sent an initial warning letter about operations at the Srikakulam and Miryalaguda plants, as well as one other, to the company in November 2015. At the time, the agency identified numerous current good manufacturing practice (CGMP) violations across the three locations.
For example, an investigation of the Srikakulam facility from Nov. 17-24, 2014, found workers were taking failed batches of API and re-testing them over and over until they passed standards. What's more, the company didn't properly safeguard electronic records for high performance liquid chromatography (HPLC), a process used to measure the chemical composition of a product.
"Anyone who accesses the system can use software administrator privileges, which means that there is no electronic or procedural control to prevent manipulation of data," the FDA said in the warning letter.
Almost a year ago, Dr. Reddy's chairman Satish Reddy pointed to U.S. oversight as a main cause of India's dwindling pharmaceutical export levels, and called for more dialogue between drugmakers in the country and the FDA. Given that the agency continues to find problems with his company's manufacturing protocols, it's clear the conversations aren't going as Reddy would have liked.