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FDA Issues New Warning Letters

Adulterated and misbranded products found during inspections at three manufacturers.

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By: Christine Esposito

Editor-in-Chief

The US FDA has posted new warning letters, including three sent to companies making personal care and OTC products.   The warning letters were addressed to Pure Sourece, LLC; Proandre SL; and Shadow Holdings LLC (dba Bocchi Laboratories).   The letter to Pure Source LLC, Doral FL followed an inspection of its drug manufacturing facility conducted from Feb. 8 to March 1, 2018, noting that there were significant violations of current good manufacturing practice (CGMP) regulations for finished ...

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