An Indian company that has had its drugs banned by the FDA has bought a contract manufacturing operation in the U.S.
Ipca Laboratories announced Wednesday that it has paid $9.65 million to acquire Pisgah Labs, an API maker based in Pisgah Forest, North Carolina. It said the Pisgah operations would “dovetail” well with operations of its Onyx Scientific unit, a U.K. early stage API maker that it acquired in 2011.
The FDA in 2015 put the drugs from Ipca’s API plant and two formulations plants in India on its import alerts list after inspections uncovered rampant data manipulations. In a warning letter issued for the three plants in 2016, the FDA said it found Ipca employees regularly deleted failed testing data from computers and overwrote them with data that indicated APIs and products met standards.
The FDA said Ipca senior management had been told as early as 2013 about what was happening, but “failed to take sufficient corrective action and prevent the recurrence of these problems." One manager acknowledged ordering an employee to backdate records.