CLOSEOUT LETTER
Taewoong Medical Co., Ltd.
- Recipient:
- Taewoong Medical Co., Ltd.
United States
- Issuing Office:
United States
| |
| Food and Drug Administration 10903 New Hampshire Avenue White Oak Building 66 Silver Spring, MD 20993 |
Department of Health and Human ServicesSEP 18 2015
Kyongmin Shin
CEO
TaeWoong Medical Co., Ltd.
14 Gojeong-ro
Wolgot-myeon
Gimpo-si
Gyeonggi-do
REPUBLIC OF KOREA
Dear Mr. Shin:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to the Warning Letter dated November 25, 2014. Based on the Agency's evaluation, it appears that your firm has 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 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 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/
Carl Fischer, Ph.D.
Director
Division of International Compliance Operations
Office of Compliance
Center for Devices and Radiological Health