Dr reddy's second unit too gets form 483 in re audit by us drug regulator

Dr Reddy's second unit too gets Form 483 in re-audit by US drug regulator

BREAKING NEWS - In a continued setback to drug major Dr ReddyLaboratories Limited's remediation efforts, its oncology formulations facility at Duvvada in Visakhapatnam of Andhra Pradesh has received Form 483 with 13 observations from the US Food and Drug Administration(US FDA) following a fresh audit that was concluded on Thursday.

This is the second unit that has failed to clear the re-audit after the company had invited the drug regulator for a fresh evaluation of all the

three facilities that were issued a warning letter in November 2015 over some lapses in current good manufacturing practices (CGMPs).

"The US Food and Drug Administration (FDA) has issued a Form-483 with 13 observations, which we are addressing," the company said in a statement without providing any further details on nature of these observations.

The company recently announced that all the commitments as part of the warning letter response have been completed. However, the fresh observations, which point at the existence of some issues of concern from the perspective of regulatory compliance, would further prolong the scrutiny involving these units.

Last month the US drug regulator has issued Form 483 with three observations after completing audit of the company's active ingredients (APIs) manufacturing unit at Miryalaguda.

Now the active pharmaceutical ingredients (API) unit at Srikakulam in Andhra Pradesh, which is the last one of the three facilities, is about to undergo the fresh audit.

Form 483 is an observation letter issued by the US drug regulator to a pharma company at the end of an inspection if there were any violations of the Food Drug and Cosmetic Act and other related acts. The company should respond to the form 483 with a corrective action plan and then implement that expeditiously.

ARTICLE BY – BUSINESS STANDARD