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Medical Devices / Inspections and Audits

Failure to Institute Corrective Procedures Land Warning for Simpro

Sept. 7, 2016
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Failure to establish corrective and preventive action procedures as well as procedures for receiving and reviewing complaints landed Texas-based Simpro an FDA warning letter.

Although the manufacturer of non-invasive blood pressure monitors, fingertip pulse oximeters and portable fetal dopplers committed to developing a process and procedure for malfunctioning and returned products, its response didn’t demonstrate that it had developed a method to review the circumstances surrounding returned products to determine whether or not a CAPA investigation was necessary,” the Aug. 17 letter said.

Similarly, the firm committed to establish a written complaint form, but it hadn’t committed to establishing procedures for receiving, reviewing and evaluating complaints by a formally designated unit. — Tamra Sami

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