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CLOSEOUT LETTER

PROLAC, INC.


PROLAC, INC.

  

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

 
 Food and Drug Administration
466 Fernandez Juncos Avenue
San Juan, Puerto Rico, 00901
Telephone: (787) 729-8500
FAX: (787) 729-8826

January 14, 2015


15-SJN-WLCOL-04


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mr. Rafael G. De Corral
President and Owner
Prolac Inc.
Calle Oeste 2 # 15
Rio Plantation
Bayamon, Puerto Rico 00961


Dear Mr. De Corral:

We have completed an evaluation of your firm's corrective actions in response to our Warning Letter 11-SJN-WL-03 dated January 12, 2011 . Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter.

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.

Should you have questions and/or comments regarding this matter, please feel free to contact me at the district office address provided in the letterhead, and may also contact by e-mail or telephone at (787) 729-8702 or at carlosi.medina@fda.hhs.gov.


Kind regards,

/S/

Carlos I. Medina
Compliance Officer
San Juan District Office