Colon Care Products of PA, LLC

CLOSEOUT LETTER Colon Care Products of PA, LLC MARCS-CMS 460342 — October 30, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Arleen Ehritz Recipient Title Owner Colon Care Products of PA, LLC 151 Hoffman Rd Barto , PA 19504 United States Issuing Office: Center for Devices and Radiological Health 10903 New Hampshire Avenue Silver Spring , MD 20993 United States Dear Ms. Ehritz: The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS #460342 dated May 28, 2015. Based on our evaluation, it appears that you have addressed FDA concerns regarding claims 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. If you have questions relating to this matter, you may contact CDR Jeene Bailey, FNP, MS, RN at 301-796-5770 , or log onto our web site at www.fda.gov for general information relating to FDA device requirements. Sincerely, /S/ Ann M. Ferriter Director, Division of Analysis and Program Operations Office of Compliance Center for Devices and Radiological Health Content current as of: 11/13/2018 Regulated Product(s) Medical Devices