FDA Warning Letters – Drug Contamination and Manufacturing Defects

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When a drug manufacturing company issues its second pharmaceutical recall within a span of six months, a real solution to prevent manufacturing defects and contamination must be established. The first step in making sure that such reform takes place is not only through a recall, but also an FDA warning letter, which is supposed to kick a drug manufacturing company into high-gear solution decision-making.

As a Business Week report mentions, after Hospira Inc. announced a recall for Propofol and Liposyn for the second time on April 1, 2010 since six months ago, the U.S. Food and Drug Administration issued a warning letter on April 12. As two vital drugs that were sold to medical professionals and hospitals, Propofol (an anesthetic agent) and Liposyn (an intravenous nutritional product) were contaminated with particulates from the manufacturing process. Hospira recalled both of these products in October 2009 due to equipment failure at the Clayton, North Carolina manufacturing facility. Apparently, as the FDA was examining the Clayton plant in January and February, agency officials also reviewed Hospira’s Rocky Mount, North Carolina plant. It was at this second location where the FDA discovered a malfunction to authorize the processes utilized in manufacture.

While pharmaceutical products should be designed and manufactured to help people, some consumers are left to wonder whether the timeframe of these processes is cut-down in order to boost profits. If a drug maker rushes through significant elements of the manufacturing process, mistakes can be made, and flaws or defects may be left overlooked until innocent people suffer as a result. Fortunately, in the case of Propofol and Liposyn, no reports of patients experiencing serious side effects or injury have been reported at this time.

In instances where a drug company or individual breaches FDA rules, before resulting to more extreme measures, the FDA first works with the company or individual in reviewing manufacturing operations and establishing ways for regulations to be better implemented. Especially when the same two products have experienced two different issues that have prompted recalls, the FDA will also issue warning letters that are meant to encourage a drug manufacturer (or any other manufacturer or seller of medical devices, food, cosmetics, or various other products) to make and follow voluntary solutions to the issue.

Jackie Fedeli

I graduated Cum Laude from Temple University's Fox School of Business and Management in 2007. Having concentrated in Marketing, I am happy to begin my career blogging at one of Philadelphia's most prominent law firms, Anapol Schwartz.





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