FDA 483 - Vesalio - October 30, 2025

An FDA inspection conducted from October 28-30, 2025, at a specification developer firm located in San Diego, CA, identified a significant deficiency in its complaint handling procedures. The inspection resulted in the issuance of a Form FDA-483, citing a critical observation regarding the firm's failure to adequately investigate complaints involving potential device malfunctions. Specifically, the firm did not conduct a comprehensive investigation for Complaint No. 60002, which involved a patient death. Instead, the firm relied solely on the physician's conclusion that the death was not device-related, despite its own established procedure (SOP0037) mandating full investigation for all complaints. This constitutes a violation of regulatory expectations for medical device quality systems, which require manufacturers to thoroughly assess potential device failures, especially those linked to serious adverse events. Although the firm reportedly corrected this observation, the correction was not yet verified by the FDA. The firm is required to implement robust corrective actions to ensure all complaints are properly investigated to determine device compliance with specifications and prevent future recurrences, ensuring compliance with federal regulations governing medical device quality.