December 20, 2013 in Business, City

HollisterStier receives warning from FDA

By The Spokesman-Review
 
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An FDA warning letter is a notification of a “significant” violation of manufacturing guidelines. The letter cites the reasons for the notification and requires the company to identify corrective actions.

Federal regulators have issued a warning letter to Spokane’s Jubilant HollisterStier, saying an audit this year found significant problems, including a failure to ensure its pharmaceutical production line is germ-free.

A U.S. Food and Drug Administration warning letter is a notification to a manufacturer of a “significant” violation of production guidelines. The FDA letter sent last month requires HollisterStier to identify and adopt corrective actions to ensure it can guarantee sanitized conditions at its plant, at 3525 N. Regal St.

The warning letter doesn’t affect HollisterStier’s work on several drugs it currently mixes or formulates for major U.S. drugmakers.

HollisterStier doesn’t develop drugs. Pharmaceutical companies send chemical components to HollisterStier’s north Spokane plant, where they’re mixed into the final drug product, then shipped back to the developer.

The FDA action, however, does halt HollisterStier’s production of substances being developed for clinical trials before they can receive final federal approval. Such substances are referred to as new drug applications, or NDA contracts.

HollisterStier moved into contract pharmaceutical production in the early 2000s; that segment has shown strong growth in the past six years.

The company also has a large division devoted to developing and making allergy vaccines and products.

“This is not a massive disruption, but it is something we take seriously,” said Shannon Jordan, a HollisterStier spokeswoman. The company will file a reply soon and detail its response to the warning letter, she said.

HollisterStier can’t resume its NDA contracts until the FDA lifts the sanction. What’s more, the FDA noted that “other federal agencies may take this warning letter into account when considering the award of contracts.” 

HollisterStier has halted manufacturing the specific drug that was cited for irregularities during the FDA investigation, Jordan noted. The company has a policy of not divulging names of clients or the drugs they ask HollisterStier to make. Jordan added that the product in question is not a vaccine

The FDA issued the warning letter after conducting a site audit in late April and May this year.

The audit cited two broad concerns: what it termed inadequate quality-control steps at HollisterStier when its drug-mixing production lines shut down and are later restarted; and an inadequate system for use of cleaning and disinfecting agents.

In its letter the FDA said: “It is apparent that you have not implemented a robust quality system at your firm. Be advised that corporate management is responsible for ensuring the quality, safety, and integrity of drugs manufactured (by the company).”

Jordan said warning letters typically have stern statements of that kind, and this letter wasn’t intended as a “smack down” of HollisterStier.

“We’re not alone in the club of receiving warning letters,” Jordan said.

She added the company has hired outside consultants to assist in a “deep dive” and full internal audit of all the quality assurance processes used at the company’s manufacturing plant.

If a company fails to answer the FDA’s concerns, regulators have the power to shut down a company.


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