CLOSEOUT LETTER
Food for Health International, L.L.C.
- Recipient:
- Food for Health International, L.L.C.
United States
- Issuing Office:
United States
| Southwest Region |
| Food and Drug Administration Denver District Office Bldg. 20-Denver Federal Center P.O. Box 25087 6th Avenue & Kipling Street Denver, Colorado 80225-0087 Telephone: 303-236-3000 FAX: 303-236-3551 |
Department of Health and Human Services
January 13, 2014
VIA UPS
Frank L. Davis
Chief Operating Officer
Food for Health International, L.L.C.
3560 Ninigret Drive
Salt Lake City, Utah 84104
Dear Mr. Davis:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #DEN-13-1-WL issued on October 5, 2012. Based on our follow-up inspection conducted July 16-25, 2013 and our review of your subsequent FDA-483 Response, 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/
LaTonya M. Mitchell
Denver District Director
LMM/trb