FDA EIR - Pharmachem Laboratories LLC - March 15, 2022

An FDA comprehensive surveillance inspection of Pharmachem Laboratories LLC in Ogden, UT, occurred from March 8-15, 2022. Operating under 21 CFR 111 regulations for dietary supplements, this initial inspection identified several critical issues. Major violations, detailed in an FDA-483, included the company's failure to establish identity specifications for raw materials, such as specific components and probiotic species, and the absence of clear product specifications for the identity, purity, strength, and composition of finished dietary supplements. Furthermore, quality control personnel did not adequately review and approve documentation to ensure compliance with established specifications, particularly concerning varying batch sizes and raw material changes. The firm's electronic records for consumer complaints and material reviews also lacked proper controls to track entries and modifications. Verbally discussed, but uncorrected, issues included batch records missing cross-references to equipment maintenance and cleaning, and an SOP inaccurately defining identity testing requirements. The company was advised to submit a written response to these observations within fifteen business days. Failure to address these concerns could lead to further regulatory actions, including warning letters, injunctions, or product seizure.