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  5. Sage Products Inc - 520382 - 09/05/2019
  1. Warning Letters

CLOSEOUT LETTER

Sage Products Inc MARCS-CMS 520382 —

Delivery Method:
UPS Next Day
Signature Required
Product:
Drugs
Recipient:
Recipient Name
Kevin A. Lobo
Recipient Title
Chairman & CEO
Sage Products Inc
Stryker Corporation

2825 Airview Boulevard
Kalamazoo, MI 49002
United States

Issuing Office:
Division of Pharmaceutical Quality Operations III (PHRM3)

300 River Place
Suite 5900
Detroit, MI 48207
United States

(313) 393-8100

Dear Mr. Lobo:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of Sage Products, Inc.’s corrective actions in response to our warning letter [Case #520382, July 17, 2017]. 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.

Sincerely,
/S/
Nicholas F. Lyons
Compliance Director
Division of Pharmaceutical Quality Operations III

cc: Mr. Donald E. Payerle
      Vice President and General Manager
      Sage Products, Inc.
      3909 Three Oaks Road
      Cary, IL 60013

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