Mylan has suffered a further manufacturing setback at its flagship facility in Morgantown, US, after the US Food and Drug Administration (FDA) issued the site with a warning letter concerning its finished-dosage forms. Following an inspection at the plant from 19 March to 12 April, the agency identified “significant violations” of current good manufacturing practice (cGMP) and said it may withhold new approvals linked with the site.
The FDA said that Mylan’s cleaning validation and verification program for manufacturing equipment “is inadequate to prevent cross contamination”. “Your firm has had many recurring incidents in which visible drug residues were found on non-dedicated equipment after the equipment was deemed clean by multiple staff,” the agency observed. In January, Mylan opened an investigation after a technician found “visible residues of nitrofurantoin in the form of a yellow powder” on the encapsulation machine, after producing batches of verapamil extended-release capsules, a white-powdered drug product
