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ByHeart, Inc. was cited for significant violations of infant formula Current Good Manufacturing Practice (CGMP) requirements under 21 C.F.R. Part 106 at its powdered infant formula manufacturing facility in Pennsylvania. FDA investigators found deviations related to quality control procedures, quality factors, records and reports, and notifications during an inspection conducted from December 2022 through February 2023. As the parent company and owner responsible for all decisions regarding its infant formula products, ByHeart was determined to have violated the Federal Food, Drug, and Cosmetic Act and the Infant Formula Rule, with the company submitting multiple corrective action responses between March and July 2023.