FDA Cites Fresenius Kabi Plant for Manufacturing Lapses After Patient Adverse Events

The FDA issued a warning letter to Fresenius Kabi's Melrose Park facility for failing to investigate manufacturing deviations linked to adverse events from famotidine injections. The agency found the company released batches despite bioburden exceedances, leading to endotoxin failure and a recall. This highlights regulatory scrutiny over drug manufacturing quality and patient safety.