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CLOSEOUT LETTER

Pax-All Manufacturing Inc. 16/04/2015

Pax-All Manufacturing Inc. - Close Out Letter 4/16/15


Pax-All Manufacturing Inc.

  

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

Public Health Service
Food and Drug Administration
CENTER FOR DRUG EVALUATION AND RESEARCH
 Office of Manufacturing Quality
Division of Drug Quality I
Global Compliance Branch 2
10903 New Hampshire Avenue
Building #51, Room 4212
Silver Spring, MD 20993

TELEPHONE: (301) 796-3916
                FAX: (301) 847-8742

 

April 16, 2015

Juvenal Alvarez
President
Pax-All Manufacturing Inc.
5000 Howard Business Parkway
Windsor, Canada

Reference: FEI 3003986222 (previous FEI 3005318686)


Dear Mr. Alvarez:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter WL: 320-12-13 dated March 9, 2012. 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,

/S/

Maan Abduldayem
Compliance Officer
Division of Drug Quality I