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  5. Shenzhen Creative Industry Co., Ltd. - 484188 - 05/08/2019
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CLOSEOUT LETTER

Shenzhen Creative Industry Co., Ltd. MARCS-CMS 484188 — May 08, 2019

Shenzhen Creative Industry Co., Ltd. - 484188 - 05/08/2019

Product:
Medical Devices

Recipient:
Recipient Name
Wang 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