FDA 483 - Insite One - October 31, 2025

InsiteOne, LLC underwent an FDA inspection from October 30-31, 2025, which resulted in the issuance of a Form FDA-483. The primary observation highlighted a significant deficiency in the company's procedures for receiving, reviewing, and evaluating complaints. Specifically, InsiteOne, LLC had not adequately established or followed its own complaint handling processes to determine if complaints were reportable as Medical Device Reports (MDRs).

The firm's internal "Complaint Handling" Standard Operating Procedure (SOP82-002, Rev. D), effective August 31, 2025, mandates in Section 4.4 that a complaint owner analyze complaints for MDR reportability. However, the FDA investigator observed that this critical step was not being consistently performed. This indicates a failure to adhere to the quality system requirements for medical device manufacturers under the Federal Food, Drug and Cosmetic Act.

While the FDA-483 represents inspectional observations and not a final determination of compliance, InsiteOne, LLC is now required to address these findings. The company must develop and implement corrective actions to rectify the identified procedural shortcomings and is responsible for conducting comprehensive internal self-audits to ensure full compliance with all applicable quality system regulations. A formal response detailing these actions must be submitted to the FDA.