Gold Medal Hair Products warning letter
This article was originally published in The Rose Sheet
Executive Summary
Jan. 13 FDA warning letter states that the firm's OTC drugs including Carbonoel Medicated Scalp Ointment and Carbonoel Medicated Liquid Shampoo are adulterated due to firm's failure to comply with Good Manufacturing Practice Regulations for Finished Pharmaceuticals. The letter cites several violations including failure to establish a written testing program to assess product stability, ensure that mechanical and electronic equipment was inspected and include the identity and strength of each active ingredient