Carolina Liquid Chemistries Corp

CLOSEOUT LETTER Carolina Liquid Chemistries Corp MARCS-CMS 573596 — November 02, 2020 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Recipient: Recipient Name Patricia A.G. Shugart, Philip Shugart Recipient Title Chief Operating Officer, CEO Carolina Liquid Chemistries Corp 313 Gallimore Dairy Rd. Greensboro , NC 27409 United States pattigaull@aol.com Issuing Office: Office of Medical Devices and Radiological Health Operations Division 3/West United States Dear Ms. & Mr. Shugart, The Food and Drug Administration has completed an evaluation of your corrective actions in response to a Warning Letter dated 7/31/2019. 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. Sincerely, /S/ Jessica Mu Compliance Branch Director Office of Medical Devices and Radiological Health Operations Division 3/West Content current as of: 11/18/2020