The US FDA has said that it is concerned about Wockhardt's responses to the health regulator's queries and lab records are not in compliance with established standards. It also added that comany did not take appropriate actions to resolve defects while actual samples were used as 'trial' injections.
As a result the net impact on the annualised consolidated revenue is expected to be less than £1 million, out of the total annual consolidated revenue of approximately £18 million, from the said facility, it added.
The company, however, said Medicine and Healthcare Products Regulatory Agency, UK, (UKMHRA) has eased the restrictions to an extent allowing it to supply most of the products manufactured at the said facility to the UK.