Impax Laboratories, Inc.
) recently announced that the US Food and Drug Administration
(FDA) completed its re-inspection of the company's manufacturing
facility at Hayward.
The re-inspection was undertaken due to a previously disclosed
Form 483 issued in Mar 2012.
Additionally, the FDA conducted a Pre-Approval Inspection
(PAI) for candidate Rytary in order to validate the analytical
method undertaken. Rytary is being developed for the symptomatic
treatment of Parkinson's disease.
Further, the FDA also conducted a general Good Manufacturing
Practices (GMP) inspection and observed deviations from the
current practices by Impax.
We note that Impax has been hampered by quality control issues
since 2011. In May 2011, Impax received a warning letter from the
FDA after an inspection of the company's facility at Hayward. The
inspection was conducted between Dec 13, 2010 and Jan 21,
Subsequently, Impax responded to the warning letter and
received an acknowledgement letter for a complete response from
the FDA in Dec 2011.
Thereafter, in 2012, the FDA completed a re-inspection of the
concerned facility along with a general GMP inspection and issued
Form 483 with its observations. A satisfactory re-inspection by
the FDA is mandatory to close the warning letter.
However, the outcome of the re-inspection was not positive for
Impax. After the latest inspection, the FDA has issued a new Form
483 with 12 observations. Out of these12, 3 are repeat
observations from inspections that occurred prior to the warning
Impax expects to respond to these new observations within 15
business days from the receipt of Form 483. The news impacted the
Impax is working diligently on the issues noted by the FDA and
expects to resolve the matter quickly. However, the new Form 483
remains a major overhang on the stock.
Impax currently carries a Zacks Rank #4 (Sell). Right now,
) look well placed in the pharma space. All three stocks carry a
Zacks Rank #2 (Buy).
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