Delivery Method: VIA Electronic Mail Product: Drugs
Recipient:

Recipient Name

Douglas Yoch

Recipient Title

Pharmacist-In-Charge

Stanley Specialty Pharmacy Compounding and Wellness Center

3120 Latrobe Dr.
Ste. 200
Charlotte, NC 28211-2185
United States

Issuing Office: Drug Product/Adulterated

United States

Mr. Yoch:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [Case # 557711; dated July 24, 2018]. 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 ensure 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/
John W. Diehl, M.S
Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division II
U.S.