- Delivery Method:
- VIA UPS
- Reference #:
- Dietary Supplements
Recipient NameAlfredo Bala
- Mannatech Incorporated
600 South Royal Lane
Coppell, TX 75019
- Issuing Office:
- Office of Human and Animal Food-West Div. 3
Dear Mr. Bala:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (2018-DAL-WL-2) issued on November 14, 2017. 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.
Recall Coordinator/Compliance Officer
Office of Human and Animal Food-West Div. 3