CLOSEOUT LETTER
Shenzhen Creative Industry Co., Ltd. MARCS-CMS 484188 —
- Product:
- Medical Devices
- Recipient:
-
Recipient NameWang Jia
- Shenzhen Creative Industry Co., Ltd.
2/F, Block 3
Nanyou Tianan
Shenzhen Shi
Guangdong Sheng, 518054
China
- Issuing Office:
- Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring, MD 20993
United States
Dear Ms. Wang Jia:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated 01/15/2016 and the inspection conducted on 11/05-08/2018. 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 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/
Bram Zuckerman
Director
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health