- Delivery Method:
- VIA Electronic Mail
- Medical Devices
- Issuing Office:
- Division of Medical Device and Radiological Health Operations Central
- (407) 475-4700
Dear Mr. Marchionne:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 606266) issued on April 16, 2020. Based on our evaluation, it appears that you have addressed the violations(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.
Director Compliance Brach
Office of Medical Device and Radiological Health Division 2