CHUNGDO PHARM. CO. LTD. - Close Out Letter 7/21/17
- CHUNGDO PHARM. CO. LTD.
10903 New Hampshire Avenue
Silver Spring, MD 20993
JULY 21, 2017
ChungDo Pharm. Co.LTD.
202 HI-TECH VENTURE TOWN
JUL z l 2on
Korea, Republic of (South) 200-160
Dear Shon Kim:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated July 30, 2013. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this Warning Letter.
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. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Donald J. St. Pierre
Acting Deputy Director for
Patient Safety and Product Quality
Office of In Vitro Diagnostics
and Radiological Health
Center for Devices and Radiological Health