The US Food and Drug Administration (USFDA) on Monday directed Dr Reddy’s Laboratories to get a third party assessment of its three manufacturing plants for which it received a “warning letter” last week.
Country’s second largest drug maker is in the process of shifting some of the products to other plants in the wake of the warning letters. Besides, the company also hinted that the USFDA warning might affect new drug approvals as well even while the company is taking corrective measures.
In a conference call with the analysts, CEO of Dr. Reddy’s Laboratories GV Prasad said: “We have instituted corrective actions to assess the Form 483 observations received earlier for these sites. The recent letter underscores the need for us to re-evaluate the work done in the light of the observations made by the FDA and continue to implement the process. The FDA wants us to focus on the warning letter and also get the third party verification and third party evaluation for certain things and also do it across our manufacturing network.”
On November 6, 2015, the company reported that it received a warning letter from the USFDA over inadequate quality controls at three manufacturing plants producing drugs for cancer and other diseases. Also, it received a warning letter from the US drug regulator relating to two of its active pharma ingredients (API) manufacturing plants and a formulation plant located in Andhra Pradesh and Telangana. The FDA issued a warning letter on November 5 relating to its API manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as oncology formulation manufacturing facility at Duvvada, Visakhapatnam, Andhra Pradesh.
The warning letter followed the earlier inspections of these sites by the agency in November 2014, January 2015 and February 2015, respectively.