FDA 483 - Beauty Manufacturing Solutions Corp. - April 07, 2021

Beauty Manufacturing Solutions Corp., an OTC human drug contract manufacturer in Coppell, TX, was cited for significant deficiencies in its quality control unit and computer system controls. The firm's quality unit lacked authority to investigate errors and failed to review audit trails for critical release testing instruments, leading to the release of numerous batches without proper data integrity checks. Additionally, analysts had unauthorized access to modify methods and results on computerized systems, compromising data integrity.