FDA 483 - USpharma Ltd - June 23, 2022
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USpharma Ltd, a prescription and OTC drug manufacturer in Miami Lakes, FL, was cited with three observations during an FDA inspection. The observations indicate significant deficiencies in laboratory controls, including unestablished test method sensitivities, incomplete laboratory records for stability testing, and a failure to thoroughly investigate unexplained discrepancies in quality control results. These issues suggest potential risks to product quality and data integrity.
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