U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Irvin, Inc. - 612738 - 09/27/2021
  1. Warning Letters


Irvin, Inc. MARCS-CMS 612738 —

Medical Devices

Recipient Name
Denise Cannon
Recipient Title
Irvin, Inc.

3542 Pineville-Rock Hill Rd (SC Hwy 51)
Fort Mill, SC 29715
United States

Issuing Office:
Center for Devices and Radiological Health

United States

Dear Ms. Cannon:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 612738, May 27, 2021). Based on our evaluation, it appears that you have addressed the violation(s) 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 Agency 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 yours,
Donna Engleman, MS, BSN
Director Division of Market Intelligence
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Back to Top