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  5. Drive DeVilbiss Healthcare LLC - 619182 - 10/23/2024
  1. Warning Letters

CLOSEOUT LETTER

Drive DeVilbiss Healthcare LLC MARCS-CMS 619182 —

Product:
Medical Devices

Recipient:
Recipient Name
Derek Lampert
Recipient Title
Chief Executive Officer (CEO)
Drive DeVilbiss Healthcare LLC

99 Seaview Blvd, Suite 210
Port Washington, NY 11050
United States

Issuing Office:
Office of Medical Device and Radiological Health Operations (Division 1)

United States

Secondary Issuing Offices

United States


Dear Mr. Lampert:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS # 619182, dated November 23, 2021. Based on our evaluation, it appears that you have addressed the violation(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.


Sincerely,
/S/
RDML Sean M. Boyd, MPH, USPHS
Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

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