Warning Letter: Failure to document digital changes and complaints (ucm421235)

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Ofni Systems

No records of identification, validation or verification, review, or approval were available for design changes to the SimulCare resulting in the SimulCare II. The changes included new digital controls… Failure to ensure that suppliers and contractors were evaluated and selected based upon their ability to meet specified requirements, as required by 21 CFR 820.50(a)(1). Specifically, your firm utilizes various suppliers for components of your devices, including PCBs [Printed Circuit Boards]…your firm failed to record and document investigation of oral complaints related to burnt-out microchips… Specifically, the SimulCare II was cleared under K083202; however, your firm’s promotion of the device provides evidence that the device was modified including a change from analog knobs utilized to control the strength and duration of therapy to digital button controls now utilized for the same function.

View the original warning letter.


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