The company had received 14 complaints about its Pump in Style Advanced electric breast pump that tell of the device’s motors and transformers failing during use, according to the FDA.
The FDA inspected the McHenry, Ill.-based company’s facility in the Fall of 2010 and found that it was falling short of the agency’s “current good manufacturing practice” requirements for medical devices, the warning letter said.
The company responded to the FDA on its observations made during the Fall inspection, but the agency subsequently determined that the company had failed to “adequately establish and maintain procedures for implementing corrective and preventive action,” according to the warning letter. The agency determined that the company did not maintain sufficient records of complaints or establish a system to adequately evaluate the reported device failures. The agency also stated that the company failed to document all testing of the Pump in Style Advanced devices during its manufacture.
The FDA also alleged that the company failed to report two incidences of serious injuries caused by the use of the breast pump.
The FDA considers the breast feeding products medical devices because “they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.”
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