Creative Science, Inc.

CLOSEOUT LETTER Creative Science, Inc. MARCS-CMS 554119 — October 08, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Next Day Product: Drugs Recipient: Recipient Name Bradley H. Butler Recipient Title President/CEO Creative Science, Inc. 455 Sovereign Ct. Ballwin , MO 63011 United States Issuing Office: Division of Pharmaceutical Quality Operations III 300 River Place Suite 5900 Detroit , MI 48207 United States (313) 393-8100 Dear Mr. Butler: We received your July 3, 2018, and August 16, 2018, letters and August 22, 2019, and September 6, 2019, email communications in response to Warning Letter Case# 554119. Your letters and email communications have been made a part of the Food and Drug Administration’s (FDA) permanent file for your firm. The FDA has completed an evaluation of your corrective actions in response to the warning letter. Based on our evaluation, it appears that you have addressed the violations contained in the warning letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Nicholas F. Lyons Compliance Director Division of Pharmaceutical Quality Operations III Content current as of: 11/01/2019 Regulated Product(s) Drugs