Custom Assemblies, Inc.

CLOSEOUT LETTER Custom Assemblies, Inc. MARCS-CMS 540535 — June 15, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Mr. William A. J. Peacock Recipient Title President Custom Assemblies, Inc. 330 East Main Street PO Box 177 Pine Level , NC 27568 United States Jack.Peacock@customassemblies.com Kathy.Jackl@customassemblies.com Issuing Office: Office of Medical Device and Radiological Health Operations Division 2 Central United States (407) 475-4700 Dear Mr. Peacock: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS # 540535 dated April 06, 2018. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future 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/ Blake Bevill, MS Program Division Director OMDRHO Division 2 - Central Content current as of: 06/29/2020 Regulated Product(s) Medical Devices