CLOSEOUT LETTER
Hangzhou Facecare Cosmetics Co., Ltd. MARCS-CMS 537146 —
- Product:
- Drugs
- Recipient:
-
Recipient NameJohn Wu
-
Recipient TitleGeneral Manager
- Hangzhou Facecare Cosmetics Co., Ltd.
No. 755 Yinhai Road
HEDA
Hangzhou Shi
Zhejiang Sheng, 310018
China
- Issuing Office:
- Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Silver Spring, MD 20993
United States
Dear Mr. Wu:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter: 320-18-09 dated November 17, 2017. Based on our evaluation, it appears that you have 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. 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/
Bryce Hammer
Compliance Officer
Global Compliance Branch IV
Division of Drug Quality II
CDER/OC/OMQ