Indoco Remedies receives six 483s for Goa plant from US FDA

The US Food & Drug Administration (FDA) has issued six 483s to Indoco Remedies Ltd’s Goa plant II. Form 483s were issued after the US drug regulator inspected the company's Goa plant II from August 31, 2016 to September 4, 2016 in connection with ANDA filings for injectable. 

“At the end of the inspection, six 483s were issued. All the observations (483s) are correctable and the company expects to complete the corrective and preventive actions within a period of 30 days. None of the 483s are related to data integrity issue,” said Indoco Remedies in a BSE filing yesterday.

An FDA Form 483 is issued by US FDA to the company at the end of an inspection if the investigators observe any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act. Normally, companies are asked to respond to the Form 483 in writing with their corrective action plan, which then needs to be implemented expeditiously.