Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil - 614402 - 06/05/2026

Reference #:

FEI 3010166780

Product:

Drugs

Recipient:

Recipient Name

Ms.Gulten Erdemir

Recipient Title

General Manager

Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil

Bolgesi Aydinli Sb Mahallesi 6 12 Istanbul Endustri Veticaret Serbest 34953 Sokak Tuzla/İstanbul Turkey

Issuing Office:

Center for Drug Evaluation and Research (CDER)

United States

Secondary Issuing Offices

United States

Dear Ms. Erdemir:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-23-11 dated February 13, 2023, and Warning Letter 320-21-51 dated July 8, 2021.

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/ Bryce Hammer Compliance Officer Division of Drug Quality II

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