Reference #: FEI 3006731547 Product: Drugs Recipient:

Recipient Name

Mr. Young-Gi Son

Recipient Title

President

Natuzen Co., Ltd.

289 Namdongdong-Ro
Namdong-gu
Incheon
21639
South Korea

Issuing Office: Center for Drug Evaluation and Research (CDER)

United States

Secondary Issuing Offices

Dear Mr. Son:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-24-36 dated May 3, 2024.

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/
Joel Hustedt
Compliance Officer
Division of Drug Quality II

Content current as of:

03/11/2025

Source

Medically Reviewed By: Felicia Eddings, Pharm.D.

Clinical :: Oncology :: Nuclear :: Geriatric :: Regulatory :: Technology :: Consulting

"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.

Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.