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Home » New Form 483 Slows Impax Pipeline, Adds to Hayward Remediation Plan
New Form 483 Slows Impax Pipeline, Adds to Hayward Remediation Plan
May 8, 2012
Amid ongoing efforts to address a previous FDA warning, Impax Laboratories has been hit with a fresh Form 483 after a general inspection unearthed additional quality issues at the company’s Hayward, Calif., facility, further complicating a growing ANDA backlog, the drugmaker says.