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Impax hit by FDA re-inspection failure

pharmafile | March 11, 2013 | News story | Manufacturing and Production Impax, hayward 

Impax Laboratories has been hit by the news that another (FDA inspection of its troubled manufacturing facility in Hayward, California, still uncovered compliance issues.

The FDA sent a warning to Impax about the Hayward facility in May 2011 after an inspection revealed problems related to sampling and testing of in-process materials and drug products, production record reviews and failures in investigating batch failures.

The FDA has now issued a new Form 483 with 12 observations, three of which are designated as repeat observations from inspections that occurred prior to the Warning Letter, according to the company.

“While we had made progress in our remediation efforts, we still had more work to do, as evidenced by the receipt of a new Form 483, following the FDA’s re-inspection,” commented Impax’ chief executive Larry Hsu on the firm’s fourth-quarter results call recently.

The problems at Hayward have been a factor in delaying FDA approval of Rytary (carbidopa and levodopa), a new extended-release formulation of the widely-used Parkinson’s disease treatment that has been licensed to GlaxoSmithKline (GSK) outside the US and is viewed as an important growth prospect for the company.

The FDA has said it requires a satisfactory re-inspection of the company’s Hayward facility as a result of the warning letter, although Impax has tried to sidestep the issue by removing the plant as a secondary production unit in its New Drug Application (NDA) for Rytary.

In a statement, Impax said the FDA also carried out a pre-approval inspection (PAI) of the facility for the Rytary application, as “analytical method validation and a portion of the stability data were generated in Hayward”.

The company said it still hopes to launch Rytary in 2014.

Phil Taylor

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