FDA warning letter
This article was originally published in The Tan Sheet
Executive Summary
FDA warns Garland, Texas-based GDMI of "significant" current good manufacturing practice violations, including not validating cleaning procedures and failing to conduct identity testing on product from suppliers. Following its June inspection, the company outlined steps to correct violations in a June 30 letter, however, the response lacks "sufficient corrective actions," FDA says in a Nov. 27 warning letter released Jan. 19. FDA cites GDMI for marketing unapproved and misbranded OTC drugs Antiseptic Wound and Skin Cleanser, which contains benzethonium chloride 0.1 percent as the active ingredient. It notes the distributor GDMI manufactures the product for claims on its Web site that the product is effective against certain micro-organisms and diseases they cause, making the product a "drug." Products include Anti-Fungal Cream, Antifungal Treatment and Fire Ant Chigger and Bite