Cali Plant Remediation 'Impax' 110 Jobs, Mostly Manufacturing
The company has had a number of issues of late and has attributed the job loss to lower production volumes at its Hayward, California manufacturing facility caused by product discontinuances, delayed product launches and the transfer of products to the Impax’ more cost efficient Taiwan plant.
Spokesman Mark Donohue told in-Pharmatechnologist.com: “We have been transferring product to our newer Taiwan facility and we have been reviewing our product portfolio as far back as 2012,” in efforts to streamline operations and reduce expenses.
Along with reduction from discontinued products, the job loss - the majority at Hayward - is set to save the company $15m annually.
Remediation Efforts
Hayward has been at the centre of a number of issues for Impax since various manufacturing violations – including problems relating to sampling and in-process materials in both testing procedures and the review process for investigating production failure - were identified in a warning letter from the US Food and Drug Administration (FDA) in 2011.
A second FDA Form 483 issued March this year cited 12 violations including “inadequate” validation methods performed for Impax’ Parkinson’s disease treatment Rytary which was rejected by the FDA in January and led to the end of a development contract with Pharma Giant GlaxoSmithKline.
However, Donohue said the company was doing what it could to get manufacturing at Hayward back on track. “On March 21, we submitted to the FDA our responses to the recent 483 observations, including our commitment to the steps we intend to take to address the FDA observations.”
He continued, adding: “We also requested a meeting with the FDA’s San Francisco District Office to further discuss our plan – what we are doing, what we are focused on and how we are doing it – to ensure that our plan and actions are in alignment with FDA expectations.”
Production Slowing But Not Stopping
Though Donohue said Impax had for a number of years been using consultants to help on remediation efforts, last month the company hired a trio of specialists - made up of pharma veterans including former CEOs of Watson and CGM - in order to alleviate fears that Hayward was not going to return to quality manufacturing.
When asked if the job losses and transfer of operations to Taiwan signaled the company was ready to turn its back on the plant, Donohue told us that “Hayward has never stopped manufacturing product. We have three shifts in Hayward and eliminated the third shift due to the reasons” stated above.
