Baylab USA, LLC

CLOSEOUT LETTER Baylab USA, LLC MARCS-CMS 679001 — September 04, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Ashley Park Recipient Title President Baylab USA, LLC 2230 Lyndon B Johnson Fwy, Ste. 100 Dallas , TX 75234-7331 United States ashley.park@baylabusa.com Issuing Office: OHT4: Office of Surgical and Infection Control Devices, Office of Product Evaluation and Quality United States Secondary Issuing Offices United States Dear Ms. Park: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 679001, dated June 27, 2024). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ For Barbara C. Marsden Director Office of Regulatory Programs Office of Product Evaluation and Quality Center for Devices and Radiological Health cc: Justin C. Lee, Vice President of Strategic Planning, Development, and Operations justin.lee@baylabusa.com Content current as of: 09/14/2026 Regulated Product(s) Medical Devices