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  5. Stonegate Pharmacy LP - 505526 - 04/24/2019
  1. Warning Letters

CLOSEOUT LETTER

Stonegate Pharmacy LP MARCS-CMS 505526 —

Delivery Method:
UPS EXPRESS
Product:
Drugs
Recipient:
Recipient Name
Rene F. Garza, PharmD
Recipient Title
Chief Executive Officer
Stonegate Pharmacy LP

2501 W. William Cannon Drive
Suite 203
Austin, TX 78745
United States

Issuing Office:
Center for Drug Evaluation and Research

4040 N. Central Expressway
Suite 300
Dallas, TX 75204
United States

Dr. Garza:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [2017-DAL-WL-03, dated November 10, 2016]. 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/
CDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II

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