FDA 483 - Lifesignals Inc - June 21, 2025

An FDA inspection conducted at Lifesignals Inc. in Milpitas, CA, from May 19-21, 2025, revealed significant deficiencies in the company's quality system, primarily concerning Medical Device Reporting (MDR) and complaint handling procedures. The inspection, documented in an FDA Form 483 issued under the Federal Food, Drug and Cosmetic Act, identified two main observations. Firstly, the company's written MDR procedure (QOP-85-05) was found to lack an internal system for timely and effective identification and evaluation of events potentially subject to MDR requirements. It failed to define requirements for conducting investigations during the MDR evaluation process, which could lead to incorrect reportability decisions. An example cited a patient burn incident involving a biosensor (Complaint 0022). Despite an initial determination of non-reportability, a subsequent investigation revealed a device malfunction linked to overheating, yet the incident was not re-evaluated for MDR compliance. Secondly, Lifesignals Inc.'s procedures for receiving, reviewing, and evaluating complaints (QOP-85-03) were deemed inadequate. The firm did not consistently conduct or adequately document thorough complaint investigations, often failing to include comprehensive details. In the biosensor burn case, the company did not follow up with the patient to ascertain the extent of the injury or medical intervention. Furthermore, the procedures did not require the review of relevant quality records, such as device history records or non-conformance reports, during investigations into possible device failures. The company indicated a commitment to correcting these observations.