Dr. Reddy’s Laboratories is addressing a violations report issued by the US Food and Drug Administration (FDA) for Dr. Reddy’s formulation manufacturing facility in Duvvada, Visakhapatnam, India following an FDA audit of that facility that was completed on March 8, 2017, according to a company filing made with the Bombay Stock Exchange.
According to the company filing, the FDA issued Dr. Reddy’s a Form 483 with 13 observations. An FDA Form 483 is issued at the conclusion of an inspection when an investigator has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Observations are made when, in the investigator’s judgement, conditions or practices observed would indicate that any food, drug, device, or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health, according to the FDA.
The FDA Form 483 does not constitute a final agency determination of whether any condition is in violation of the FD&C Act or any of its relevant regulations. Form 483 is considered, along with a written report called an Establishment Inspection Report, all evidence or documentation collected on-site, and any responses made by the company. The FDA considers all of this information and then determines what further action, if any, is appropriate to protect public health.
The Duvvada facility is among three Dr. Reddy’s facilities that were named in an FDA Warning Letter received by the company in November 2015. In that Warning Letter, the FDA inspected three of Dr. Reddy’s Indian facilities in Ranasthalam, Srikakulam District from November 17 to 21, 2014; Tripuraram, Nalgonda District from January 26 to 31, 2015, and Duvvada from February 26 to March 6, 2015. The FDA identified significant cGMP deviations for the manufacture of active pharmaceutical ingredients at the Ranasthalam and Tripuraram facilities and found significant violations of CGMP regulations for finished pharmaceuticals at the Duvvada facility.
Source: Bombay Stock Exchange and Food and Drug Administration