Dr. Reddy’s Laboratories has received a Form 483 with 11 observations from the US Food and Drug Administration (FDA) for its formulations manufacturing plant at Bachupally, Hyderabad, India, following an FDA audit completed on April 28, 2017, according to Dr. Reddy’s in a company filing with the Bombay Stock Exchange (BSE).

Dr. Reddy’s noted that the observations were mostly procedural in nature and were related to the need to improve staff capabilities and strengthen documentation and laboratory systems. The company is in the process of addressing the observations.

This citation follows earlier citations for other Dr. Reddy’s facilities in India in recent months. In April 2017, the FDA issued a Form 483 with two observations on the company’s active pharmaceutical ingredient manufacturing plant at Srikakulam, Andhra Pradesh, and in March 2017 the agency issued a Form 483 with 13 observations on Dr. Reddy’s formulation manufacturing facility in Duvvada, Visakhapatnam, India.

Source: Bombay Stock Exchange