FDA 483 - Optim LLC - May 29, 2025

An FDA inspection of Optim LLC, conducted from May 21 to May 29, 2025, identified two significant observations related to the company's manufacturing and quality systems for nasopharyngoscopes. These findings indicate non-compliance with the regulatory framework outlined in the Quality System Regulation, specifically 21 CFR 820, which governs medical device production.

The first observation concerned the Design History File, which failed to adequately demonstrate that device designs were developed according to approved plans. A key issue was the absence of a provision in finished device acceptance testing to confirm lumen output, despite the risk management file identifying potential 'photo damage to the patient eye' from excessive illumination. Two out of ten reviewed device history records showed products exceeding specified illumination parameters.

The second observation highlighted deficiencies in the Device History Records, which did not confirm that devices were manufactured in accordance with the device master record. All ten reviewed records were found to be missing essential information, including Unique Device Identifiers (UDIs) or universal product codes, and complete finished device labeling for the manufactured nasopharyngoscopes.

Optim LLC, through its Director of Quality Assurance, Mr. Clifford L. Kites, acknowledged these issues and committed to implementing corrective actions for both observations to ensure compliance with federal regulations.