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New England Life Care, Inc. dba Advanced Compounding Solutions, an outsourcing facility registered to compound sterile drug products, failed to meet the conditions required under section 503B of the Federal Food, Drug, and Cosmetic Act, resulting in drug products that violated federal regulations. During a FDA inspection conducted from March to April 2022, investigators identified serious deficiencies in the facility's practices for producing sterile drugs, including failures to meet outsourcing facility requirements necessary for exemptions from drug approval and labeling requirements. The facility produced drug products that put patients at risk due to these manufacturing and quality control failures.