Raani Corp. warning letter
This article was originally published in The Rose Sheet
Executive Summary
Jan. 21 FDA warning letter states that the company's sunscreen lip balms and antiperspirant sticks are adulterated due to violations of Good Manufacturing Practice Regulations. The letter notes several problems, including formulation changes made without explanation or documentation, lack of waterproof testing for lip balm products for which waterproof claims are made on labeling, and failure to conduct validation studies for drug product production