FDA 483 - Pharmatech Inc. - August 09, 2023

An FDA inspection of Pharmatech Inc. in Lindon, UT, revealed significant deficiencies in the manufacturing and quality control processes for both acidified foods and dietary supplements. Observations included failures to file scheduled processes for new acidified foods, inadequate testing for dietary ingredient identity, incomplete certificates of analysis, and a lack of established contamination limits for finished dietary supplements.