Repro-Med Systems last Friday updated on a warning letter it received in February over issues the FDA found with the company’s Freedom 60 syringe infusion pump and Freedom Edge infusion pumps.
The company said it submitted a response to the warning letter last Friday to the FDA, 3 days before the required response date set by the federal watchdog.
Repro-Med said the letter responded “in great detail” to the issues brought up in the letter from the FDA, but said it would not publish the response letter due to proprietary details required to complete the response.
The company said there were no safety concerns raised in the response, and that it has not been requested to withdraw any products from the market, according to an SEC filing.
Earlier this month, Repro-Med responded to the initial letter and said it would respond hastily to the issues the agency had.
The letter was in response to an earlier reply from Repro-Med, which the FDA said was “not adequate” for handling the issues it raised, as well as laying out several aspects of the devices that were being mis-marketed, as well as failures in quality control and medical device reporting.
In the response letter, the federal watchdog said that the company’s Freedom 60 syringe and Freedom Edge infusion pumps were misbranded due to modifications made to the system.