The Evenflo Co. did not properly investigate reports that its “Comfort Select” breast pumps caused some women to suffer electric shocks. In a warning letter dated August 25, the Food & Drug Administration (FDA) also said that during inspections earlier this year, several manufacturing violations were found at two Ohio plants that make the pumps.
According to the warning letter, the FDA said Evenflo received thirty-seven complaints involving breast pumps, but did not investigate 18 of them. Three complaints highlighted by the letter involved electric shocks. The FDA noted that Evenflo’s response to this and several other violations had been “adequate.”
An Evenflo official told The Wall Street Journal that the company does investigate its consumer complaints but said the problem was a “documentation issue.”
Another violation noted in the letter included the failure to verify or validate corrective and preventive actions to ensure that such actions were effective and would not adversely affect the finished device.
The letter says that Evenflo’s response to this finding was only “partially adequate” because corrective actions did not extend to the Comfort Select pumps it sold prior to December 2008.
Develop medical device reporting procedures
The FDA also says the company still needs to develop medical device reporting procedures for its breast pumps that identify, evaluate and report complaints that might be subject to federal reporting requirements.
Evenflo had 15 working days from the date of the warning letter to notify the FDA of the specific steps the company has taken to correct the noted violations.
Failure to do so could result in regulatory action being initiated by the FDA against Evenflo. Such actions include, but are not limited to, seizure, injunction, and/or civil money penalties.
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