FDA 483 - Brands International Corporation - October 27, 2023

Brands International Corporation, an OTC drug manufacturer in Newmarket, was cited for deficiencies in its laboratory controls during an FDA inspection. The firm failed to establish scientifically sound and appropriate test procedures to ensure drug product quality and purity. Specifically, the company did not test its USP-grade ingredient or finished OTC drug products for potential Burkholderia cepacia contamination.