FDA 483 - Brio Pharmaceuticals Inc - January 24, 2020

An FDA inspection of Woodfield Pharmaceutical, LLC in Houston, TX, revealed significant deficiencies within its quality control unit. The firm failed to adequately implement procedures for investigating out-of-specification environmental monitoring results, including the presence of gram-negative organisms. Additionally, the company did not properly follow its temperature and humidity monitoring program for manufacturing rooms, failing to document temperature excursions.