CLOSEOUT LETTER
River Hills Harvest dba Elderberrylife
- Recipient:
- River Hills Harvest dba Elderberrylife
United States
- Issuing Office:
United States
| |
| Food and Drug Administration Southwest Region Kansas City District 8050 Marshall Drive Suite 205 Lenexa, Kansas 66214-1524 913-495-5100 |
Department of Health and Human ServicesDecember 9, 2015
UPS
Mr. Terry D. Durham
Owner
River Hills Harvest dba Elderberrylife
19010 S. Mackie Ln.
Hartsburg, MO 65039-9112
Dear Mr. Durham:
The Food and Drug Administration has completed our evaluation of your corrective actions in response to our Warning Letter CMS # 420427 dated April 22, 2014. 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/
Cheryl A. Bigham
District Director
Kansas City District