- Delivery Method:
- UPS EXPRESS
Recipient NameRene F. Garza, PharmD
Recipient TitleChief Executive Officer
- Stonegate Pharmacy LP
2501 W. William Cannon Drive
Austin, TX 78745
- Issuing Office:
- Center for Drug Evaluation and Research
4040 N. Central Expressway
Dallas, TX 75204
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.
CDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,