CLOSEOUT LETTER
Baylab USA, LLC MARCS-CMS 679001 —
- Delivery Method:
- VIA Electronic Mail
- Product:
- Medical Devices
- Recipient:
-
Recipient NameAshley Park
-
Recipient TitlePresident
- 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
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