Unipharma, Llc. – FDA 483, May 7, 2019

The FDA inspection of Unipharma, Llc. in Tamarac, FL, revealed significant deficiencies across its quality, production, and laboratory systems, particularly impacting over-the-counter drug products for infants and pediatric patients. Key issues included inadequate investigations into microbial contamination in purified water, release of drug products without proper Quality Assurance approval, and a lack of robust process validation and stability data to support product shelf-life. These findings indicate a serious lack of control over critical manufacturing processes and product quality, posing potential risks to public health.