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Fresenius Kabi AG's Fenwal International facility was cited for significant current good manufacturing practice (CGMP) violations in the manufacture of blood-pack units and related component solutions including Alyx, Amicus, and InterSol platelet additive solution. The company failed to follow established written procedures and adequately investigate product discrepancies, with approximately 28 batches of terminally sterilized products exceeding the firm's bioburden action limits for bulk solutions during the January 2021 to February 2022 review period. These deviations violated Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act and Title 21 CFR Parts 210 and 211, and were documented during an FDA inspection conducted in September 2022.