Wockhardt announced it had received the letter in a filing on the Bombay Stock Exchange (BSE), explaining that as a result the US regulator will not approve any new drugs made at Morton Grove’s facility in North Chicago, US.
The firm said the “current portfolio of the Company will continue to be made available in the market.”
It also said it had hired consultants to bring the plant up to code, explaining that it has “already initiated appropriate measures since last several months to address the issues raised by US FDA.”
Wockhardt bought Morton Grove in 2007, citing a desire to add the firm's range of oral liquid and topical pharmaceuticals to its US product range.
The acquisition included a 125,000 square-foot facility that has been operated by Morton Grove has been open since 1995.
The plant has been the subject of US Food and Drug Administration (FDA) already. In 2014 the US regulatory issued Morton Grove with a Form 483 detailing 12 deviations from current good manufacturing practice (cGMP).
US compliance problems
Wockhardt’s manufacturing network has also been the subject of a number of US FDA warnings.
At present Wockhardt’s drug manufacturing plants in Chikhalthana and Waluj in Aurangabad and the active pharmaceutical ingredient (API) unit in Ankleshwar, India are banned from shipping products to the US.
Wockhardt acknowledged the impact the import bans have had on its performance in its financial report for its fiscal third quarter.
The firm reported sales of INR9.95bn ($149m), down 7.4% on the year-earlier quarter, explaining that “performance during the quarter was affected by subdued business in US market, demonetisation in India and continued remediation costs.”
Wockhardt did not respond to a request for comment.
The warning letter has not been published by the FDA.