Actavis manufacturing facility subject of FDA warning letter

By Lisa Kerner

Charlotte, N.C., Sept. 14 - Actavis Group received a warning letter from the Food and Drug Administration regarding the agency's inspection of the company's solid oral dose manufacturing facility in Little Falls, N.J.

The letter highlighted deficiencies in Actavis' handling of adverse medical event reporting obligations and questioned the marketing status of the company's older products.

Actavis said it responded to the letter, revised procedures and addressed certain deficiencies to ensure continuous compliance with FDA expectations and is reviewing the marketing of its older products.

Actavis is an generic pharmaceuticals company based in Reykjavik, Iceland.

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