Delivery Method: Via Express Delivery and Electronic Mail Product: Biologics Recipient:

Recipient Name

Philip Quick

Recipient Title

Vice President of Operations

Davati Medical Supply LLC

3121 Eagles Nest St.
Suite 120
Round Rock, TX 78665
United States

[email protected] Issuing Office: Center for Biologics Evaluation and Research (CBER)

United States

Dear Mr. Quick:

The United States Food and Drug Administration (FDA) has completed evaluation of your firm’s corrective actions in response to the Warning Letter (#CBER 21-02) issued by FDA to Davati Medical Supply, LLC on June 26, 2021. Based on our evaluation, it appears that you have addressed the violation(s) contained in this WL. 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.

If you have any questions regarding this letter, please contact the Division of Case Management, CBER at (240) 402-9155 or [email protected]. Please be advised that only written communications are considered official.

Sincerely,
/S/
Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality