The US Food and Drug Administration (FDA) has warned US generics manufacturer Mylan about ‘significant violations’ at its plant in Puerto Rico.
In a warning letter sent to Mylan chairman and ceo Robert Coury, the FDA said the violations were found during a February inspection of the firm’s pharmaceutical manufacturing facility at Caguas, Puerto Rico.
Canonsburg, PA-headquartered Mylan responded to the findings in March, but the response lacked ‘sufficient corrective actions’, the FDA said.
The FDA cited Mylan’s failure to complete a content uniformity (CU) test required by the United States Pharmacopeia (USP) for anti-diarrhoea drug Loperamide Hydrochloride Capsules USP 2mg.
The regulator also said the firm did not thoroughly investigate ‘the failure of a batch or its components to meet its specifications’.
The FDA said the firm should take prompt action to correct the violations detailed in the warning letter.