Ranbaxy's Toansa plant receives US FDA warning

In the latest setback for Ranbaxy, the company has announced that it has received Form 483 warning from US Food and Drug Administration (US FDA) for its active pharmaceutical ingredient (API) manufacturing factory in Toansa, Punjab. An FDA Form 483 is issued to a company at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The FDA Form 483 notifies the company’s management of objectionable conditions.
 
Form 483 was issued to Ranbaxy, after US FDA inspected the facility last week. Though Ranbaxy can continue to supply products from this facility to the US at present, failure to address the concerns raised by US FDA could lead to a ban on all US exports from this factory.
 
“The company is assessing the observations, and will respond to the US FDA in accordance with the agency's procedure to resolve the concerns at the earliest. Ranbaxy continues to improve its systems and processes, and remains fully committed to upholding the highest standards that patients, prescribers, regulators and all other stakeholders expect from the company,” said Ranbaxy in a BSE filing.