FDA 483 - Iotamotion Inc - September 12, 2024

During an FDA inspection conducted from September 10-12, 2024, Iotamotion Inc. received a Form FDA 483 detailing significant observations concerning its quality management system. The main issue identified was that product labeling was not sufficiently examined for accuracy, including control numbers, before its release. This directly violated the firm's own Work Instruction (Ver:0, 07/21/2024, Section 5.0, 5.1 Visual Inspection).

The consequence of this oversight was the shipment of mislabeled iotaSOFT Plus Drive Unit, IM-05, Lot number D1065072024 products. Although the Device History Record was approved on August 14, 2024, mislabeled medical devices were subsequently shipped on August 20 and 23, 2024. This non-adherence impacts the integrity of their medical device products.

These observations are issued under federal regulations, specifically Section 704(b) of the Federal Food, Drug and Cosmetic Act, which governs medical device manufacturing practices. Iotamotion Inc. is responsible for promptly addressing these deficiencies. The company has indicated a commitment to correct the identified labeling issue and is expected to conduct internal self-audits to ensure full compliance with all quality system requirements.