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.
Righting manufacturing wrongs at Hayward remains a top priority at Impax, he said on the call. The company has also agreed to implement the very same corrective actions taken at its California plant at its Taiwan facility, which is currently undergoing an expansion. The FDA has not informed Impax about its inspection plans for the Taiwan facility.

What hotspots in your operation could prompt an FDA inspector to issue you a Form 483 like they did at Impax?

You can wait until the inspectors arrive to find out, or, you can get ahead of the curve by learning exactly what’s triggering citations in other companies and fixing your similar vulnerabilities before the inspector arrives.

Start now … with access to the actual Form 483s being issued to companies just like yours by ordering FDAnews’ Form 483 Watch: Drugmaker Inspections in the News.

Form 483s provide the most detailed record available of what happened during an inspection and what problems triggered citations.

Now, in one convenient source, Form 483 Watch: Drugmaker Inspections in the News provides an authoritative reference collection of the most newsworthy Form 483s issued recently to pharma manufacturers that you can learn from. Don’t delay, order this necessary tool today.