Fresenius API Facility Receives FDA Warning
The letter, dated July 1, related to an inspection made by the US Food and Drug Administration (FDA) in January 2013 where a number of GMP (Good Manufacturing Practice) non-conformities were observed at the firm’s oncolytic API plant in Kalyani, India.
An official statement by Fresenius said the firm “has made significant progress in remedying the issues cited in the Warning Letter” and the process of restarting manufacturing at the facility – following a precautionary halt in production following the inspection - has begun, based on a remediation plan submitted to the FDA.
Last news comes just a week after the firm issued a voluntary recall of four lots of Benztropine Mesylate Injection due to the potential presence of glass particles.The drug was manufactured by Allergy Laboratories on behalf of Fresenius.
