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

SRS Medical Systems Inc. in North Billerica, MA, was inspected by the FDA from October 3-11, 2023. The inspection revealed that the firm's complaint handling procedures were inadequate, specifically for "The Spanner Temporary Prostatic Stent." This deficiency led to multiple complaints remaining uninvestigated for several months without proper justification.