Home > Newsletters > The QMN Weekly Bulletin > New 483 Gums Up Impax Pipeline, Adds to Hayward Remediation Pain
The QMN Weekly Bulletin
May 4, 2012 | Vol. 4 No. 18
New 483 Gums Up Impax Pipeline, Adds to Hayward Remediation Pain
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.
Speaking on a conference call to discuss the company’s first-quarter results, Impax President and CEO Larry Hsu declined to provide details about the deficiencies but said there were no repeat observations from last year’s warning letter.
The new Form 483 comes as Impax is still working to address the issues noted in the letter and, all told, Hayward remediation is likely to incur additional costs of as much as $5 million, Hsu noted.
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