Health-Chem Acquisitions, LLC

CLOSEOUT LETTER Health-Chem Acquisitions, LLC MARCS-CMS 526232 — June 24, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Electronic Mail Product: Medical Devices Recipient: Recipient Name Jack Aronowitz Health-Chem Acquisitions, LLC 3341 SW 15th Street Pompano Beach , FL 33069 United States jaronowitz@healthchemdiagnostics.com Issuing Office: Office of Medical Device and Radiological Health Operations Division 2 Central United States (407) 475-4700 Dear Mr. Aronowitz: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated December 7, 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. Sincerely, /S/ Blake Bevill, MS Program Division Director Division 2/Central, OMDRHO Content current as of: 06/29/2020 Regulated Product(s) Medical Devices