Vision-Sciences gets FDA record-keeping warning:
This article was originally published in Clinica
Vision-Sciences has received a warning letter from the US FDA, concerning its record-keeping in regard to two of its products. They are the S-F100 Sigmoidoscope and the SS-F32 EndoSheath system, its sterile covering. The company, of Natick, Massachusetts, was cited for poor ability to review service records, product returns or complaints involving potential failure of a device. It told Dow Jones that this was the first warning it had received and that it had already addressed the topics raised by the FDA.