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  5. I. Shay Cosmetics Inc - 552754 - 12/29/2021
  1. Warning Letters

CLOSEOUT LETTER

I. Shay Cosmetics Inc MARCS-CMS 552754 —

Delivery Method:
VIA EMAIL CONFIRMED DELIVERY
Product:
Drugs
Recipient:
Recipient Name
Mr. Mehdi Ehsan
Recipient Title
President/CEO
I. Shay Cosmetics Inc

1024 E Del Amo Blvd
Carson, CA 90746-3520
United States

nick@ishaycosmetics.com
Issuing Office:
San Francisco District Office

United States

Dear Mr. Mehdi:

The U.S. Food and Drug Administration has completed an evaluation of your corrective actions in response to our warning letter (Ref CMS 552754) dated October 29, 2018. Based on our evaluation, it appears that you have adequately 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. It is your responsibility to maintain compliance and we 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.

We have concluded that the inspection conducted from November 27, 2017 to December 7, 2017 to be “closed” under 21 CFR 20.64(d)(3), and we are enclosing a copy of the narrative portion of the Establishment Inspection Report (EIR). It may reflect redactions made by FDA in accordance with the Freedom of Information Act (FOIA) and 21 CFR part 20. This, however, does not preclude you from requesting additional information under FOIA.

It is your responsibility to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and the FDA’s implementing regulations. 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, you may contact LCDR Rumany Penn, Compliance Officer, via telephone 949-608-4409 or email Rumany.Penn@fda.hhs.gov.

Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV

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