CLOSEOUT LETTER
Captain’s Cloth MARCS-CMS 613965 —
- Product:
- Medical Devices
- Recipient:
-
Recipient NameBrian Eckert
- Captain’s Cloth
28871 El Apajo
Laguna Niguel, CA 92677
United States-
- brian@captainscloth.com
- Issuing Office:
- Center for Devices and Radiological Health
United States
Dear Mr. Eckert:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 613965, July 2, 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,
/S/
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