FDA 483 - BLA Enterprises, LLC dba Green Mountain Pharmaceuticals - December 08, 2016

BLA Enterprises LLC dba Green Mountain Pharmacy, an API and dietary supplement manufacturer in Lakewood, CO, received a Form 483 with 12 observations. The inspection revealed significant deficiencies across quality systems, including inadequate investigations, lack of supplier qualification, incomplete cleaning validation, and insufficient equipment qualification. These issues indicate a systemic failure to ensure product quality, purity, and safety.