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The US Food and Drug Administration (FDA) has warned Sri Krishna Pharmaceuticals that supplies paracetamol and other drugs to more than 60 countries.
The company is based in the southern Indian city of Hyderabad and is the latest drugmaker in the country to get such a warning.
The FDA has found during an inspection in December 2014 that staff at one of the company’s plants in Hyderabad deleted unfavourable test results and manipulated records to show products it made there adhered to quality standards.
The findings had been listed by the agency in a “warning letter” dated April 1 and addressed to Krishna Pharma’s Chairman V.V. Subba Reddy and a copy of that was posted on the FDA website on Tuesday.
Officials at krishna Pharma did not respond to a requests for comment on Wednesday morning.
The FDA has given warning a year after Canada’s health regulator had said that it stopped importing raw materials from Sri Krishna Pharma over data integrity concerns.
