CLOSEOUT LETTER
Edge Biologicals Inc MARCS-CMS 660003 —
- Delivery Method:
- VIA Electronic Mail
- Product:
- Medical Devices
- Recipient:
-
Recipient NameWalter C. Edge III
-
Recipient TitleVice President
- Edge Biologicals Inc
598 N 2nd Street
Memphis, TN 38105-1634
United States-
- cal@edgebiological.com
- Issuing Office:
- Division of Medical Device and Radiological Health Operations Central
United States
United States
Dear Mr. Edge:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 660003, dated June 27, 2023). Based on our evaluation, it appears that you have addressed the violations 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/
Barbara C. Marsden
Acting Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health