U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. The Skin Atelier, Inc. d.b.a. Skinprint - 582512 - 10/29/2024
  1. Warning Letters

CLOSEOUT LETTER

The Skin Atelier, Inc. d.b.a. Skinprint MARCS-CMS 582512 —

Reference #:
FEI 3005976760
Product:
Drugs
Recipient:
Recipient Name
Mr. Robert P. Manzo
Recipient Title
President/CEO
The Skin Atelier, Inc. d.b.a. Skinprint

1997 Route 17 M, Suite 10
Goshen, NY 10924
United States

Issuing Office:
Division of Pharmaceutical Quality Operations I

United States

Secondary Issuing Offices

United States

Dear Mr. Manzo:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 582512 dated October 1, 2019.

Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter pertaining to CGMP violations. 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/
Emily Wu
Compliance Officer
Division of Drug Quality II

Back to Top