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Custom Assemblies, Inc. MARCS-CMS 540535 —

Medical Devices

Recipient Name
Mr. William A. J. Peacock
Recipient Title
Custom Assemblies, Inc.

330 East Main Street
PO Box 177
Pine Level, NC 27568
United States

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.

Blake Bevill, MS
Program Division Director
OMDRHO Division 2 - Central

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