U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Praxair Inc. - 09/21/2015
  1. Warning Letters

CLOSEOUT LETTER

Praxair Inc.


Recipient:
Praxair Inc.

United States

Issuing Office:

United States


  

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

 
 New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433

September 21, 2015

Mr. Stephen F. Angel, President, Chairman & CEO
Praxair Inc.
175 E. Park Drive
Tonawanda, NY 14150-7844

Dear Mr. Angel:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2015-16 dated January 7, 2015. 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/

LCDR Catherine M. Beer, USPHS
Compliance Officer
FDA - New York District


cc: Mr. Stephen F. Angel, President, Chairman & CEO
     Praxair Inc.
     39 Old Ridgebury Road
     Danbury, CT 06810-5113

cc: Mr. Michael E. Skrjanc, Director, Regulatory Compliance and Product Safety
     Praxair Inc.
     39 Old Ridgebury Road
     Danbury, CT 06810-5113

Back to Top