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  5. Formology Lab Inc. - 644745 - 12/19/2024
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CLOSEOUT LETTER

Formology Lab Inc. MARCS-CMS 644745 —

Reference #:
FEI 3014278936
Product:
Drugs
Recipient:
Recipient Name
Mr. Oren Ezra
Recipient Title
Owner and Chief Executive Officer
Formology Lab Inc.

9174 Deering Avenue
Chatsworth, CA 91311-5801
United States

Issuing Office:
Division of Pharmaceutical Quality Operations IV

United States

Secondary Issuing Offices

United States

Dear Mr. Ezra:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS 644745 dated March 1, 2023.

Based on our evaluation, it appears that you have addressed the violations 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 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/
Yumi Hiramine
Compliance Officer
Division of Drug Quality III

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