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FDA bans production at New Jersey compound firm over sterility issues

July 09, 2013
KEYWORDS fda / pharmaceuticals
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Josiah Garber/iStockphoto/Thinkstock
Photo credit: Josiah Garber/iStockphoto/Thinkstock

The U.S. Food and Drug Administration (FDA) has taken action against New Jersey-based compounding pharmacy Med Prep Consulting, Inc. over concerns relating to the sterility of its production. A federal judge at the U.S. District Court for New Jersey has entered a consent decree of permanent injunction against the company and its president and owner, Gerald R. Tighe, on behalf of the agency, the FDA has announced.

Med Prep is a manufacturer of sterile drug products and its production is supplied to hospitals and health care centers, including products that are injected in patients' vascular systems. Failure to ensure sterility might put the lives of patients at risk and lack of sterility assurance was one of the reasons behind the FDA's action.

The consent decree means that Med Prep will not be able to manufacture, store and distribute drug products unless it complies with all requirements under the Federal Food, Drug, and Cosmetic Act and other applicable regulations, the FDA statement explained.

Melinda K. Plaisier, the agency's acting associate commissioner for regulatory affairs, commented that all businesses that act in breach of regulations will face serious consequences. The consent decree should act as a warning to all those who believe they can violate federal and state regulations and it proves that the FDA is committed to taking all measures necessary to ensure drugs that reach the U.S. market are safe for consumers.

The FDA started action against Med Prep following an inspection at the company's facility at Tinton Falls, N.J., in March. Inspectors found the drug products were manufactured under insanitary conditions and noticed a series of violations of other requirements for drug production. Moreover, the inspection revealed the presence of mold in certain injectable drug products, which were labeled as sterile, and analysis of samples showed that some of the products contained less active ingredients than standards required.

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FDA officials also reported that Med Prep manufactured and distributed drug products without having obtained patient-specific prescriptions in advance and without having a drug products application approved by the FDA. On March 18, the company recalled all of its sterile products. There are no reports of injury or illness linked with Med Prep products but all these violations of good manufacturing practices are a serious issue and Med Prep will remain under scrutiny in the future. The company put patients' health at risk by making contaminated drug products, manufactured in unacceptable conditions, stated Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

The FDA has recently taken a firmer stance on pharmaceutical companies that produce sterile drugs, especially in the aftermath of last year's deadly fungal meningitis outbreak. Since September 2012 the agency has managed to carry out 60 inspections at state-licenced facilities, with half of those resulting from a report of adverse events. Over the same period, the FDA has controlled 14 voluntary recalls of products, most of which took place due to lack of sterility concerns, the agency announced.

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