Dr. Reddy’s Laboratories is based in Hyderabad, Telangana, India. The company produces some 190 drug products for India and overseas markets, including U.S. and Europe.
The new warning from FDA applies to three of the company’s manufacturing plants. These are: Srikakulam (Andhra Pradesh); Miryalaguda (Telengana); and Duvvada (Visakhapatnam in Andhra Pradesh.) Two of the plants make active pharmaceutical ingredients and the other manufactures oncology drugs.
The letter means all U.S. approvals from the manufacturing sites are suspended until remediation actions are taken. The reason for the FDA action is because of a series of quality control issues.
A warning letter from the FDA is given only in the most serious of cases. When FDA inspects a facility and find matters of concern they issue a form-483. The company is given 30 days to respond with an action plan. If the action plan is acceptable, the company only needs to act on the plan and notify FDA when it is complete. However, if FDA is not satisfied and thinks that practices pose a potential risk to users of the products, a warning letter is issued.
Due to the volume of products produced from the plants (around 10 percent of Dr. Reddy’s output), shares in the company fell, according to News Daily. In response, the head of the company, GV Prasad stated: “We take quality and compliance matters seriously and stand by our commitment to fully comply with cGMP quality standards across all of our facilities. We will respond with a comprehensive plan to address these observations within the stipulated timeframe of 15 days.” cGMP refers to “current Good Manufacturing Practices”, which are set out in the U.S. Code of Federal Regulations and describe the minimum standards expected of pharmaceutical manufacturers in terms of producing a safe and efficacious product.
Dr. Reddy’s has received previous criticisms about the quality of its products. In June 2011, the company’s generic simvastatin tablets were recalled because the tablets were reported as having a “musty” or “moldy” smell. Three years later, the company recalled a heart medication due to formulation issues. Then, in December 2014, FDA issued a warning letter about the company’s Srikakulam manufacturing facility.
