FDA 483 - Brio Pharmaceuticals Inc - January 24, 2020
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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.
ID · 8a324c13-c0cb-47bb-9009-6c5849d9d466