Praxair Inc

January 7, 2015

WARNING LETTER NYK-2015-16

VIA UNITED PARCEL SERVICE

Mr. Stephen F. Angel, President, Chairman & CEO
Praxair Inc.
175 E. Park Drive
Tonawanda, NY 14150-7844
FEI: 1000448358

Dear Mr. Angel:

During an inspection of your firm located in Tonawanda, NY, on July 29, 2014 through August 8, 2014, an Investigator from the United States Food and Drug Administration (FDA) determined that your firm is a medical device specification developer of, in part, various ‘gas flow regulators intended to administer oxygen to patients at a specific flow rate’. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.

Quality System Violations

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Last Updated: 2016-03-09

Praxair Inc