FDA Marks Down Compounder for Aseptic Shortfalls

August 31, 2017

A Tennessee compounding pharmacy fell short of standards for aseptic production in making sterile drugs, the FDA said.

In a Form 483 issued after an inspection in June, the FDA said the compounder, DCA Pharmacy, of Franklin, released for sale batches of products that did not meet specifications for strength, purity or quality of ingredients.

Workers at the compounder, used non-sterile wipes to clean a sterile area, and left a sterile workroom, touched surfaces or items outside the workroom and then returned to the workroom without disinfecting or changing gloves, the agency said.

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