A U.S. District Judge has shuttered a New Jersey-based manufacturer of medical products for manufacturing and distributing contaminated drugs and other products and for failing to meet the minimum federal standards for safety and current good manufacturing practice requirements, the U.S. Justice Department said in a statement.
Med Prep Consulting Inc. of Tinton Falls, N.J., was ordered to halt production after a Connecticut hospital discovered intravenous drugs containing visible contaminants and reported the products to the U.S. Food and Drug Administration (FDA). FDA officials investigated and found the injectable drugs contained mold.
Med Prep manufactures a range of drug products that are supposed to be sterile, including pain medications, anesthesia, operating room drugs, oncology drugs, and dialysis drugs. FDA investigators found that the company did not have approved new drug applications for any of the products it produced.
According to a complaint filed against Med Prep by the Justice Department and the U.S Attorney’s office in New Jersey, Med Prep failed to create and follow appropriate procedures to prevent contamination of drugs it purported to be sterile. The complaint says the company failed to properly clean and maintain its manufacturing equipment to ensure the safety of its drugs, resulting in the distribution of injectable drugs that contained visible mold.
“Med Prep put patients at risk by producing contaminated drugs under unacceptable conditions,” said Melinda K. Plaisier, Acting Associate Commissioner for Regulatory Affairs for the FDA. “The Department of Justice and FDA will continue to work together to protect the health of Americans by taking aggressive enforcement actions to ensure the safety of drugs.”
“Under this resolution, Med Prep cannot manufacture or distribute drugs until it fully complies with the consumer protections set forth in the law,” said Stuart F. Delery, Assistant Attorney General for the Justice Department’s Civil Division. “Patients who take injectable drug products contaminated with mold are at risk of major illness or death. This settlement requires Med Prep to clean up its act before its products are allowed to return to market.”
The consent decree against Med Prep mandates that the company must correct its violations and take numerous measures outlined in the injunction to ensure its violations will not occur again, in addition to retaining a safety inspector at the manufacturing facility.