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.
Hsu also said the company has not been told by the FDA what impact the latest Form 483 will have on the resolution of the May 31, 2011, warning letter, which found deviations related to sampling and testing of in-process materials and drug products, among other things
What hotspots in your operation could prompt an FDA inspector to issue you a Form 483? 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.
New from 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, this guideprovides an authoritative reference collection of the most newsworthy Form 483s issued recently to pharma manufacturers.
What are you waiting for? Order your copy today!