FDA issues warning letters to Baxter and Olympus over GMP and QSR violations

The U.S. Food and Drug Administration sent formal warning letters to Baxter International and Olympus Medical Systems.

The letters allege that both companies failed to meet required good manufacturing practice standards and Quality System Regulation requirements.

Regulators highlighted specific deficiencies that could affect product quality and patient safety, and they expect the firms to implement corrective actions promptly.

The notices serve as a reminder that compliance oversight remains a priority for the FDA and may influence future inspections of similar manufacturers.