FDA WARNING_LETTER - Newman Lasik Centers, LLC

On December 16, 2011, the FDA issued a Warning Letter to Newman Lasik Centers, LLC, following an August 8, 2011, inspection in Hercules, California. The inspection determined the firm is a medical device user facility, subject to Medical Device Reporting (MDR) regulations (21 CFR Part 803) for its ophthalmic lasers.

The firm's devices were found to be misbranded under Section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act due to failure to furnish required information under Section 519 and 21 CFR Part 803. A significant violation was the failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. Specifically, the MDR procedure lacked an effective date and failed to establish a standardized review process for determining reportable events, including clarity on who makes reportability decisions in the absence of designated personnel. Additionally, the procedure did not describe how the facility would address documentation and record-keeping for evaluated information, submitted reports, and systems for timely follow-up and FDA inspection.

The FDA requires prompt corrective action to prevent regulatory actions such as seizure, injunction, or civil money penalties. The firm must respond in writing within fifteen business days, detailing specific steps taken to correct violations, prevent recurrence, and provide a timetable for any ongoing actions. The response should be