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  5. Professional Disposables International, Inc. - 617201 - 12/05/2024
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CLOSEOUT LETTER

Professional Disposables International, Inc. MARCS-CMS 617201 —

Reference #:
FEI 2411192
Product:
Drugs
Recipient:
Recipient Name
Mr. Zachary Julius
Recipient Title
CEO
Professional Disposables International, Inc.

4855 Pine Tree Drive
Miami Beach, FL 33140
United States

Issuing Office:
Division of Pharmaceutical Quality Operations I

United States

Secondary Issuing Offices

United States

Dear Mr. Julius:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 617201 dated January 07, 2022.

Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter pertaining to Professional Disposables International, Inc., FEI 2411192. 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 FDA 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/
Emmanuel Ramos
Compliance Officer
Division of Drug Quality III
Office of Manufacturing Quality

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