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

An FDA inspection of Beauty Manufacturing Solutions Corp. in Coppell, TX, was conducted from March 30 to April 7, 2021. This compliance inspection assessed the firm's adherence to 21 CFR Part 210/211, Current Good Manufacturing Practices for Finished Pharmaceuticals, and evaluated the adequacy of their corrective actions following a previous warning letter and inspection in 2018. While the firm's responses to prior deficiencies appeared adequate, the current inspection identified two main objectionable conditions, resulting in an FDA Form 483. First, the quality control unit lacked proper authority and written procedures to review audit trails for computerized systems, specifically HPLC and ICP instruments used in the release testing of over-the-counter topical drug products. This led to numerous batches being released without adequate audit trail review. Second, the firm failed to exercise appropriate controls over these computerized systems, as analysts and chemists had the ability to modify methods, alter sample sets, or abort results without investigation or authorized approval from the quality control unit. Management acknowledged the observations and committed to providing a written response to the FDA within 15 business days, outlining their planned corrections.