The FDA issued a warning letter to Mylan for “significant violations” of manufacturing rules identified during a February inspection of a manufacturing plant in Caguas, Puerto Rico. Mylan spokeswoman Nina Devlin said that the drugmaker will work closely with the FDA to fully address the letter “and believe we will be able to address this matter expeditiously.”
In the letter, U.S. regulators noted that the company failed to complete a required test meant to ensure uniformity of the medicine content and failed to fully investigate the failure of a batch or its components to meet required specifications. The only drug cited in the agency’s letter was a generic version of the anti-diarrhoeal Imodium.
The spokeswoman noted that while the issue is being addressed, “production and shipment of product from the Caguas facility continues uninterrupted.”