483
CoreRX Inc.FDA 483 - CoreRX Inc. - June 21, 2019
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Record Details
An FDA inspection of CoreRx Inc. in Clearwater, FL, a drug product manufacturer, revealed three significant observations. The firm failed to establish scientifically sound test procedures for dissolution, did not maintain proper calibration records for equipment, and neglected to extend incident investigations to other relevant batches.
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ID · 4c534536-5911-42dd-8cf5-a28e860ef746