FDA 483 - CoreRX Inc. - January 24, 2014
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An FDA inspection of CoreRx Inc. in Clearwater, FL, revealed significant deficiencies in equipment design and qualification, investigation procedures, process control, and equipment calibration. The firm failed to ensure manufacturing equipment suitability, conduct thorough investigations into discrepancies, justify deviations from procedures, and maintain proper calibration records for critical equipment. These issues indicate a lack of adequate quality control and compliance with manufacturing standards.
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