FDA 483 - Zarbee's Inc - December 11, 2017

An FDA inspection of Zarbee's Inc., a dietary supplement own label distributor in Draper, UT, revealed a significant quality control deficiency. The firm failed to ensure finished batches of Infant Gripe Water conformed to product specifications, relying on an unverified "Quantified by Input" method. This practice lacked proper documentation and scientific justification, raising concerns about product quality and regulatory compliance.