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  5. Creative Science, Inc. - 554119 - 10/08/2019
  1. Warning Letters

CLOSEOUT LETTER

Creative Science, Inc. MARCS-CMS 554119 —

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

 
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