Mumbai: The US Food and Drug Administration (FDA) has issued form 483 to Aurobindo Pharma Ltd’s unit-IV in Hyderabad with seven observations relating to violation of good manufacturing practices, according to information on the drug regulator’s website.
The US FDA had inspected unit-IV, where the company manufactures injectables and ophthalmic products, during 20-28 April.
The US FDA issues a form 483 if its investigators spot any condition that in their judgement may constitute violations of the US Food Drug and Cosmetic (FD&C) Act and related Acts.
At 11:45am, shares of Aurobindo Pharma were down 1.2 per cent to Rs596.15 on the BSE, while the benchmark Sensex index was up 0.1 per cent at 29,949.69 points.
Two key lapses that the drug regulator observed at the unit were: Appropriate controls over computers were not exercised to ensure that changes in master production and control records are instituted only by authorized personnel, and procedures designed to prevent microbiological contamination of products purporting to be sterile were not established.
The US FDA also observed that buildings were not maintained in good state, manufacturing equipment not maintained and appropriately designed to achieve the intended purpose, laboratory controls did not include appropriate test procedures, changes to written procedures were not drafted, reviewed and approved by the appropriate unit and batch distribution not reviewed thoroughly.
The issues highlighted by the US FDA at the unit do not appear to be very severe and the company will be able to address them soon, a research analyst at a domestic brokerage house, who did not wish to be named, said.
According to Aurobindo Pharma, product filings with the US FDA from unit-IV were 75 as on 31 December 2016, of which the company has got marketing approval for 38 products.
On 19 April 2017, the US FDA had issued form 483 to the company’s unit-III in Hyderabad, used for manufacturing oral formulations, with six observations relating to violation of norms.