- Delivery Method:
- VIA UPS
Recipient NameJoel J. Meyerson
- Pure Source LLC
9750 NW 17th Street
Doral, FL 33172-2753
- Issuing Office:
- Center for Drug Evaluation and Research
The Food and Drug Administration has completed the evaluation of corrective actions in response to our Warning Letter (WL # 555240), dated February 20, 2019. 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.
John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
CC: Renee Alsobrook, Chief
Department of Business and Professional Regulation
Division of Drugs, Devices and Cosmetics
Compliance and Enforcement
2601 Blair Stone Road
Tallahassee, Florida 32399-1047