FDA 483 - SRS Medical Systems Inc. - October 11, 2023

An FDA inspection of SRS Medical Systems Inc., a medical device manufacturer located in North Billerica, MA, was conducted from October 3 to October 11, 2023. The inspection, performed under the authority of the Federal Food, Drug, and Cosmetic Act, revealed a significant observation concerning the company's quality system. Specifically, the firm's procedures for receiving, reviewing, and evaluating product complaints were deemed inadequate. The primary issue identified was that the company's "Spanner Product Line Complaint Handling System" procedure failed to ensure complaints were processed uniformly and in a timely fashion. Investigators cited an example where six out of seventeen reviewed complaints related to "The Spanner Temporary Prostatic Stent" remained open and uninvestigated for five to eight months after the product was returned, without any documented justification for these prolonged delays. The FDA 483 report indicates that the firm is responsible for conducting internal self-audits to identify and correct all violations of quality system requirements. SRS Medical Systems Inc. reportedly committed to correcting the identified complaint handling deficiency within five weeks. The company is expected to implement comprehensive corrective and preventive actions to address these observations and ensure ongoing compliance with regulatory standards.