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  5. JD & SN Inc., dba Moses Lake Professional Pharmacy - Close Out Letter 8/9/18
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CLOSEOUT LETTER

JD & SN Inc., dba Moses Lake Professional Pharmacy


Recipient:
JD & SN Inc., dba Moses Lake Professional Pharmacy


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
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