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Home » Impax Hit With 483: Company Not Rejecting Failed Drugs, Following SOPs
Impax Hit With 483: Company Not Rejecting Failed Drugs, Following SOPs
June 1, 2012
Agency inspectors found Impax Laboratories failed to reject drug products that did not meet established standards and specifications, an FDA Form 483 states, shedding light on the quality issues found at the company’s troubled Hayward, Calif., facility.