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For many years, the FDA seemed to turn its attention away from medical gases. In 2011, the medical gas industry saw some increased inspection activity and inspection severity among medical gas companies in the Northwest, the Midwest and New England. GAWDA’s FDA & Medical Gases Consultant Thomas L. Badstubner discusses the FDA inspection trends and preparation in “Recent FDA Enforcement Activities.” His article appears in Welding & Gases Today, the leading magazine for the gases and welding equipment industry.

Over the last 16 years, FDA warning letters to medical gas companies have gone from over 120 a year at the peak in 1997 to less than 10 per year for the last several years. However, increased inspection activity in 2011 means distributors must be prepared. Certain key areas must be assessed to prepare for an FDA inspection.

Medical gas distributors should be sure all production records have been properly completed. This includes making sure all signatures and dates are entered, each record has been released and all discrepancies have been investigated and reviewed by the Quality Control Unit (QCU). In one recent audit, the FDA found minor errors on 0.5 percent of the logs and cited the firm for violation of Current Good Manufacturing Practices (cGMP).

Training records, orderliness, maintenance records and expiration dates are all areas that require attention. To learn more about medical gas regulations, read “Recent FDA Enforcement Activities” (http://www.weldingandgasestoday.org/index.php/2012/01/recent-fda-enforcement-activities/ ) at Welding & Gases Today Online. For more information, contact Devin O’Toole, content editor at Welding & Gases Today at devin@weldingandgasestoday.org or 315-445-2347.

About GAWDA
Founded in 1945, the Gases and Welding Distributors Association (GAWDA) is the premier source for manufacturing knowledge, education and networking. Through its member journals (http://www.weldingandgasestoday.org), e-magazines, newsletters and industry wiki (http://www.gawdawiki.org), GAWDA connects suppliers of gases and manufacturers of related equipment as well as manufacturers of welding equipment and distribution leaders, for the purpose of safely delivering optimal solutions to the users of those products. GAWDA publications are the industry’s voice for all matters related to the latest technology and the most up-to-date processes spanning welding equipment and products and services related to industrial, medical, specialty and cryogenic gases. A 501(c)3 organization, GAWDA members are located throughout North America.

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