FDA EIR - Deseret Laboratories, Inc. - March 23, 2018

A routine FDA inspection of Deseret Laboratories, Inc., an OTC and homeopathic drug, food, and dietary supplement manufacturer located in Saint George, UT, was conducted from March 19-23, 2018. The inspection, performed under relevant Good Manufacturing Practices (GMP) regulations (Compliance Program 7356.002), revealed several significant deficiencies, leading to the issuance of a FORM FDA 483 with four observations. Key violations included the failure to perform routine calibration of mechanical and electronic equipment according to a written program, with some equipment used past its calibration due date and others never calibrated. Master production and control records were found deficient, lacking complete manufacturing instructions, specific procedures for documenting production settings, and clear guidance for initiating investigations into out-of-specification results or deviations. Laboratory controls were also cited for not ensuring scientifically sound specifications, notably the absence of quality unit review for incoming laboratory materials and missing growth promotion data for microbial testing media. Furthermore, laboratory computer systems lacked individual password protection and audit trail functionality, raising concerns about data integrity. Finally, the firm's stability testing records were incomplete, with microbial test results missing for several homeopathic drug products. Management, represented by Chief Operating Officer/CFO Mark H. Gubler, acknowledged the observations and committed to providing a written response within 15 business days, outlining their corrective actions. The FDA informed the company that these conditions could be considered violations of the Food, Drug and Cosmetic Act, potentially leading to a warning letter, prosecution, seizure, or injunction.