In Brief: Solar Cosmetic Labs
This article was originally published in The Rose Sheet
Executive Summary
Solar Cosmetic Labs: Miami, FL-based sunscreen manufacturer receives FDA warning letter in December citing deviations from Current Good Manufacturing Practice (CGMP) regulations for drugs. The violations outlined in the Dec. 6 FDA letter include: failure to assure that sunscreens have met standards of strength, quality and purity; failure to "validate the analytical method for percent active ingredients"; failure to perform or maintain adequate stability testing; and failure to establish that the SPF rating is kept through a three-year shelf life. The letter also cites the company's lack of written procedures for the cleaning and maintenance of equipment, the handling of consumer complaints and the testing of raw materials and lab controls. In a Jan. 31 letter to FDA, the Miami-based company confirmed that "all actions have been taken to correct the violations"...