FDA 483 - VALENCIA NATURALS, INC - May 11, 2022

VALENCIA NATURALS, INC, a Class II medical device manufacturer of personal lubricants in Chatsworth, CA, was cited for three observations during an FDA inspection. The firm failed to maintain complete design history files and adequately document design risk analyses for its personal lubricant products. Additionally, the company did not establish proper quality supplier agreements with its contract manufacturer.