Delivery Method: VIA Electronic Mail Product: Drugs
Recipient:

Recipient Name

Kevin Schneider

Intrathecal Compounding Specialists, LLC

206A Jacob’s Run
Scott, LA 70583-8907
United States

Issuing Office: Division of Pharmaceutical Quality Operations II

United States

Dear Mr. Schneider:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL 610639) dated September 15, 2020. 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/
H.L Jamillah Selby
Acting Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division II