Mr. Steven Myers
3055 New Street
Oceanside, NY 11572
Dear Mr. Myers:
The Food and Drug Administration has completed evaluation of your firm's corrective actions in response to our Warning Letter CMS# 605076, issued on June 18, 2021. Since issuance of the Warning Letter, there have been changes in the responsible firm operations. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter pertaining to your firm. 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.
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1