Regulatory Focus™ > News Articles > Sterility Issues Found at Second Compounder as FDA Anticipates New Drug Shortages

Sterility Issues Found at Second Compounder as FDA Anticipates New Drug Shortages

Posted 01 November 2012 | By Alexander Gaffney, RAC

Officials with the US Food and Drug Administration (FDA) have announced the voluntary recall of all products made by Ameridose, a pharmaceutical compounder whose sister company is linked with a massive outbreak of fungal meningitis, as well as the possibility that the massive recall could lead to new shortages of pharmaceutical products.

According to Ameridose, FDA had informed it that it would be, "Seeking improvements in Ameridose's sterility testing process." The New England Compounding Center (NECC), owned by the same group as Ameridose, was recently the recipient of a lengthy and alarming Form 483 inspection report detailing significant failings of NECC's sterility procedures.

FDA's 483 report stated, "Although the formula worksheets state the raw materials are sterile, the Pharmacy Director stated that the firm uses non sterile active pharmaceutical ingredients (APIs) and raw materials, with the exception of sterile water for injection, to formulate injectable suspensions." The company relied on an autoclave to sterilize the products once they were compounded, but FDA observed that it had not validated the device's impact on sterility.

"Ameridose and FDA agree that the use of injectable products that are not sterile can represent a serious hazard to health and could lead to life-threatening injuries and/or death," the company said in a statement. Though it said it had not received any adverse event reports or impurities, it said it was initiating the recall, "Out of an abundance of caution."

FDA did not indicate whether the same sterility issues found at NECC were found at Ameridose's facility.

FDA, in a separate statement, said its investigators remain at Ameridose's Westborough, MA compounding facility, and that its "preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by this facility."

FDA cautioned that the recall could negatively affect drug shortage situations across the country. In the wake of ongoing shortages, some hospitals have become increasingly reliant upon pharmaceutical compounders to meet their patients' needs.

"FDA is aware many hospitals and clinics across the country are customers of Ameridose and that the current production shutdown of Ameridose may impact supplies of certain drugs for some health care systems," it wrote. "FDA's top priority is to ensure that drugs are safe for the American public and we are working with Ameridose to ensure that this is the case."

Information on new drug shortages would be communicated to healthcare professionals as FDA was made aware of them, it said.

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