FDA 483 - Armand Products Company - October 01, 2019

Armand Products Company, Inc. in Muscle Shoals, AL, a drug component manufacturer, was cited for significant contamination issues during the production of potassium bicarbonate, USP. The firm's manufacturing system is known to leach contaminants and shed metal pieces, a problem they have been aware of since at least September 2017 without implementing corrective actions. Despite frequent detection of metal during packaging, contaminated batches were released as USP grade material.