FDA warns Mylan over Puerto Rico plant


Violations found during inspection in February

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.

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