Delivery Method: Via Email Product: Medical Devices

Recipient:

Recipient Name

Nathan A. Folkert

Recipient Title

Chief Executive Officer

Orchid Orthopedic Solutions, LLC CEP Bio-Coat, LLC

1489 Cedar Street
Holt, MI 48842
United States

[email protected]
Issuing Office: Center for Devices and Radiological Health

United States


Dear Mr. Folkert:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 580112) issued on May 13, 2019, at CEP Bio-Coat/Orchid Orthopedic Solutions, LLC, located at 23149 Commerce Drive, Farmington Hills, MI,, FEI 3011277306. 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 yours,
/S/
Gina M. Brackett
Director, Compliance Branch
Office of Medical Device & Radiological Health
Division-1 East
Office of Regulatory Affairs
U.S. Food and Drug Administration