The company’s shares rose 3% in early trading on November 19, after an audit of the company’s site by the US Food and Drug Administration (FDA) in Andhra Pradesh, India, saw zero observations.
In a Bombay Stock Exchange filing, Dr. Reddy’s stated that the audit of its Formulations Srikakulum Plant Unit II received zero observations. The filing occurred during post-market hours on Friday, the following Monday shares jumped.
Between October 22 and October 30, 2018, however, Dr. Reddy’s site in Visakhapatnam, India, was observed by the FDA and it noted ten observations that led to the issuing of a Form 483 for its site. The observations generally regarded the Quality Unit and proper implementations to maintain sterile products.
The FDA states on its website that a Form 483 is distributed at the conclusion of an inspection when observations regarding conditions that may constitute violations to the Food Drug and Cosmetic Act are seen.
The company’s Duvvada site, which primarily manufactures generic chemotherapy treatments, was issued a Form 483. A site in Bollaram and another in Jinneram Mandal were also recently given observations following audits.