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  5. Colon Care Products of PA, LLC - 460342 - 10/30/2018
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CLOSEOUT LETTER

Colon Care Products of PA, LLC MARCS-CMS 460342 —

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

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