Better Health Lab, Inc - Close Out Letter 9/12/16
- Better Health Lab, Inc
Department of Health and Human Services
|Food and Drug Administration|
|New Jersey District Office|
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
September 12, 2016
VIA UNITED PARCEL SERVICE
Robert Kim, Owner and Managing Director
Better Health Lab, Inc.
200 S Newman Street, Unit 1
Hackensack, New Jersey 07601
Dear Mr. Kim:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 15-NWJ-04, dated February 18, 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 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.
Acting Director Compliance Branch
New Jersey District Office