The unit inspected in August by the US Food and Drug Administration was issued a Form 483 with seven observations of violations of good manufacturing practices.
Shares of Aurobindo Pharma fell 3.3 percent on Friday to Rs 694 on the National Stock Exchange after the company said that its Unit-I in Hyderabad has received a warning letter from the US drug regulator.
The bulk drug manufacturing unit inspected in August by the US Food and Drug Administration was issued a Form 483 with seven observations of violations of good manufacturing practices.
The observations included inadequate evaluation and qualification of critical material suppliers, inadequate sampling plans for raw materials and intermediates, and components used in manufacturing not being tested and released prior to use.
Other observations are: proposed changes were not adequately evaluated, quality control failed to ensure investigations were scientifically sound and equipment was not properly maintained and documented at the time of performance, a CNBC-TV18 report said.
All this implies that the company will not get approvals in the US for new products filed from the unit. “The firm believes that this will not impact the existing business from this facility,” Aurobindo Pharma said.
The company added that it is engaging with the US drug regulator to resolve the issues.
The facility manufactures active pharmaceutical ingredients or bulk drugs for cardiovascular, central nervous system, anti-allergics and non-sterile cephalosporins.
