FDA 483 - Valentine Enterprises, Inc. - October 24, 2024

Valentine Enterprises, Inc., a dietary supplement manufacturer in Lawrenceville, GA, was cited for significant deficiencies in quality control and record-keeping during an FDA inspection. Observations included failure to establish complete product and component specifications, releasing adulterated products due to inadequate microbial testing, and releasing out-of-specification products. The firm also lacked comprehensive Master Manufacturing Records and Batch Production Records.