FDA 483 - Pharmachem Laboratories LLC - March 15, 2022

Pharmachem Laboratories in Ogden, UT, a dietary supplement manufacturer, received a Form 483 citing significant deficiencies in quality control and manufacturing processes. Observations included failures to establish identity specifications for components and finished products, lack of approved documentation for specification compliance, and inadequate controls for electronic records. These issues indicate a systemic breakdown in ensuring product quality and regulatory adherence.