Yamashin Company, Ltd. - Close Out Letter 10/11/17
- Yamashin Company, Ltd.
- Issuing Office:
5001 Campus Drive
October 11, 2017
Mr. Shinichi Okajima, President
Yamashin Company, Ltd.
Hekinan City, Aichi Japan
Dear Mr. Okajima:
The Food and Drug Administration has completed an evaluation of your client’s corrective actions in response to our Warning Letter Re: 449878 issued March 10, 2015. 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 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 client to maintain compliance and will continue to monitor your client’s state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Latasha A. Robinson, M.S.
Dietary Supplement Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition