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Walfer Corporation dba The Medicine Shoppe Pharmacy, a compounding pharmacy in Port Charlotte, Florida, produced adulterated drug products that failed to meet the exemption requirements under Section 503A of the Federal Food, Drug, and Cosmetic Act. FDA investigators found serious deficiencies in the pharmacy's manufacturing practices during a March 2020 inspection, including production of sterile compounded products without valid prescriptions for individually-identified patients and failure to comply with current good manufacturing practice (CGMP) standards. The violations put patients at risk, prompting the pharmacy to initiate recalls of all drug products within expiry and cease sterile product manufacturing.