FDA 483 - BLA Enterprises, LLC dba Green Mountain Pharmaceuticals - December 13, 2021

BLA Enterprises, LLC dba Green Mountain Pharmaceuticals, a drug manufacturer in Lakewood, CO, was cited for significant deficiencies across its quality, production, and labeling systems. The inspection revealed inadequate investigations into discrepancies and out-of-specification results, a failure to conduct required internal audits, and a lack of proper process validation and record-keeping for master batch records. Additionally, the firm did not maintain strict control over labeling reconciliation.