FDA Rips Unsanitary Practices Of India Drug Co. In Mylan Buy

Law360, New York (September 26, 2013, 1:12 PM EDT) -- An Indian drugmaker being acquired by Mylan Inc. employed highly unsanitary practices when producing sterile medications, using hole-ridden gloves and mold-tainted shipping containers, according to a U.S. Food and Drug Administration warning letter released Tuesday.

The lengthy and strongly worded letter to Agila Specialties Private Ltd. focused in large part on contamination risks associated with allegedly faulty gloves used by workers filling vials of injectable drugs, with the FDA describing “visible holes and flaking” in the gloves.

In addition, boxes used to ship the gloves were...
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