CLOSEOUT LETTER
Baxter Healthcare Corp.
- Recipient:
- Baxter Healthcare Corp.
United States
- Issuing Office:
United States
| |
Chicago District Office 550 W. Jackson Blvd., 15th Floor Chicago, IL 60661 Telephone: (312) 353-5863 Fax: (312) 596-4187 |
February 8, 2017
José E. Almeida
Chief Executive Officer
Baxter International
1 Baxter Parkway
Deerfield, IL 60015
Dear Mr. Almeida:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CHI-2-14 dated January 17, 2014. Based on our evaluation, it appears that you have addressed the violation(s) contained in this 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 Agency 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/
William R. Weissinger
District Director