- Wealth PMS (50L+)
CP Pharmaceuticals Limited – one of the Step-down subsidiaries of Wockhardt based at Ash Road North, Wrexham Industrial Estate, Wrexham LL13 9UF, Wales, UK which reported a PAT of Rs. 179.08 crore for the year ended March, 2016. (turnover amounted to Rs. 553.52 crore) has been slapped with a warning letter from the US FDA in relation to the significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. This comes after the company responded to the inspection results on November 3, 2015 followed by a couple of more updates.
The principal activity of the subsidiary is Manufacturing and Sale of Pharmaceuticals as well as research and manufacturing activity on customer products & manufacturing technologies.
Wockhardt said in a press release to the Bombay Stock Exchange that the mentioned subsidiary does not have any business in the United States (USFDA is the regulatory authority of United States) and that the CP Pharmaceuticals has already initiated the required steps.
The U.S. Food and Drug Administration (FDA) inspected the drug manufacturing facility, from 5-9 October, 2015 and again from 12-13 October, 2015.
While there were just 2 detailed observations made, the firm’s response to these observations were poorly drafted from a CGMP Compliance perspective.
The FDA has now asked the company to provide a copy of the current risk assessment and all the actions to be taken as a result of this risk assessment to be performed by the company.
Failure to correct these violations may result in FDA refusing admission of articles manufactured at CP Pharmaceuticals, Ash Road North, Wrexham Industrial Estate, Wrexham, United Kingdom, into the United States.