JD & SN Inc., dba Moses Lake Professional Pharmacy

CLOSEOUT LETTER JD & SN Inc., dba Moses Lake Professional Pharmacy MARCS-CMS 485637 — August 09, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: JD & SN Inc., dba Moses Lake Professional Pharmacy United States Issuing Office: United States Division of Pharmaceutical Quality Operations IV 19701 Fairchild Road, Irvine, CA 92612 Telephone: (949) 608-2900 Fax: (949) 608-4417 August 9, 2018 Shawn W. Needham, R.Ph., President JD & SN Inc., dba Moses Lake Professional Pharmacy 1555 Pilgrim St. Moses Lake, Washington 98837-4623 Dear Mr. Needham: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter dated October 14, 2016. From June 28, 2017, to July 12, 2017, an FDA investigator conducted a follow-up inspection of your facility, JD & SN Inc., dba Moses Lake Professional Pharmacy, located at 1555 Pilgrim St., Moses Lake, Washington 98837-4623. We acknowledge that your firm receives valid prescriptions for individually-identified patients for all of the drug products you produce. We also acknowledge that your firm no longer produces sterile drug products or drug products containing domperidone. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter. You are expected to take all necessary steps to assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ CAPT Katherine Jacobitz Acting Director, Division of Pharmaceutical Quality Operations IV FEI 3004603767 CMS 485637 Content current as of: 09/18/2018