CLOSEOUT LETTER
AZ Instrument (Shen Zhen) Co., Ltd.
- Recipient:
- AZ Instrument (Shen Zhen) Co., Ltd.
United States
- Issuing Office:
United States
| Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human Services
JAN 05, 2015
MS. MAGGIE CHU, PRESIDENT
AZ INSTRUMENT (SHEN ZHEN) CO., LTD.
BLDG #21 BAOKE IND. PARK, LUNG KO
DALOUNG, LONGHUA, BAO'AN, SHENZHEN
GUANGDONG, 518109, CHINA
Dear Ms. Chu:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #162012 dated March 04, 2011. 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/
Alberto Gutierrez
Director
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and
Radiological Health