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CLOSEOUT LETTER

Baxter Healthcare SA/dba Baxter Healthcare of Puerto Rico Oct 02, 2015

Baxter Healthcare SA/dba Baxter Healthcare of Puerto Rico - Close Out Letter 10/2/15


Baxter Healthcare SA/dba Baxter Healthcare of Puerto Rico

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Food and Drug Administration
 San Juan District
466 Fernandez Juncos Avenue
San Juan PR 00901-3223
Telephone: (787) 729-8500
FAX:          (787) 729-6658
 

October 2, 2015

16-SJN-WLCO L-01

CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mr. Robert L. Parkinson
Chairman, President and CEO
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield, IL, 60015-4633

Dear Mr. Parkinson:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 14-SJN-WL-10 dated 07/17/2014. Based on our evaluation, it appears that you have addressed the violations 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 yours,

/S/

Edwin Ramos
Director of Compliance
San Juan District Office


cc:
Mr. Enrique Moran
Plant General Manager
Baxter Healthcare
SA/dba Baxter Health Care of PR
Carr.#721 Km 0.31
Aibonito, PR 00705