Madison Polymeric Engineering MARCS-CMS 456082 —
- Madison Polymeric Engineering
- Issuing Office:
Office of Medical Devices and Radiological Health Operations (Division-1)
DELIVERED VIA UPS
October 26, 2017
Walter L. Maguire, Jr.
Madison Polymeric Engineering
965 West Main Street
Branford, CT 06405
Dear Mr. Maguire:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, CMS Case 456082, issued on April 22, 2015. 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.
Office of Medical Device & Radiological Health
Office of Regulatory Affairs