Atlanta Supersource, Inc. Warning Letter Details

Summary

Atlanta Supersource, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations at its drug manufacturing facility in Kennesaw, Georgia, involving the production of INSTANT HAND SANITIZER Rinse-Free Gel and Rinse-Free Foam products. The FDA found that the company failed to properly clean, maintain, sanitize, and sterilize manufacturing equipment and utensils at appropriate intervals, resulting in adulterated drug products that were also misbranded. The company's response to the initial FDA 483 inspection findings was deemed inadequate, lacking sufficient detail and evidence of corrective actions needed to achieve CGMP compliance.