Dr Reddy's UK plant receives inspectional observations

Dr Reddy's Laboratories Limited's Active Pharmaceutical Ingredients (API) plant in Mirfield, UK, has received three inspectional observations (Form 483) from the US Food and Drug Administration (US FDA) following the completion of its audit yesterday.

The company's US FDA approved the site at Mirfield has two dedicated API manufacturing facilities, a GMP pilot plant and kilo lab, a commercial facility for intermediates manufacture.

"This is to inform you that audit of our API Mirfield plant, UK, by the US FDA has been completed today. We have been issued Form 483 with three observations, which we are addressing," the company said