FDA 483 - Capstone Nutrition, LLC - September 21, 2017

Cornerstone Research and Development, a dietary supplement manufacturer in Ogden, UT, was cited for five observations during an FDA inspection. The firm failed to maintain proper storage conditions for reserve samples and products, lacked a corrective action plan for out-of-specification events, did not follow contamination prevention procedures during manufacturing, and failed to calibrate instruments accurately. These issues indicate significant deficiencies in quality control and manufacturing practices.