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Medical Devices / Inspections and Audits

Failure to Institute Corrective Procedures Land Warning for Simpro

Sept. 7, 2016

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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