CLOSEOUT LETTER
WHPM Inc. MARCS-CMS 629146 —
- Delivery Method:
- VIA Electronic Mail
- Product:
- Medical Devices
- Recipient:
-
Recipient NameDr. John Wan
-
Recipient TitleCEO & President
- WHPM Inc.
5358 Irwindale Ave.
Ste. B
Irwindale, CA 91706
United States-
- johnwan@whpm.com
- Issuing Office:
- Office of Medical Device and Radiological Health Division 3
United States
Dear Dr.Wan:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (WL #629146) dated June 30, 2022. 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,
/S/
Jessica Mu
Director, Compliance Branch
Office of Medical Device and Radiological Health Operations
Division 3