Recent FDA Enforcement Activities

For many years, the FDA seemed to turn its attention away from medical gases. Our industry seems to have been perceived as having a relatively lower risk than other heavily enforced industries (seafood, clinics, clinical investigators, etc.) The chart shows the number of warning letters issued to medical gas companies over the last 16 years.

In 2011, we began to see some increased inspection activity and inspection severity among GAWDA members in three regions (Northwest, Midwest and New England). It’s too soon to know if this is a trend which will continue or expand. However, no matter where your business is located, this is a prudent time to closely examine your medical gas compliance. We recommend that certain key areas be assessed to best prepare for your own FDA inspection. These areas are easy to survey, but painful to explain to FDA investigators if they are out of compliance. At the end of this article are links to additional resources in your compliance efforts.

FDA Warning Letter Historical Trend

Production Records
First be sure all records have been properly completed. All signatures and dates are entered. Each record has been released. 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
Be sure all operators, drivers and members of the QCU have received documented cGMP training within the last 12 months. Be sure drivers are trained never to modify or force a fitting on a cryogenic liquid container. Be sure all operators have received documented training on filling/testing medical gases within the last three years.

Orderliness
Be sure all medical gas cylinders are segregated from non-medical gas cylinders. Assure you have no evidence of rodent infestation. Be sure the housekeeping is good. Be sure your manifolds are clean. Be sure the gloves used for medical gas operations are clean for medical service as well as clean for oxygen service. Use a periodic cleaning and maintenance inspection record.

Maintenance Records
All medical gas equipment (tanks, high pressure pumps, vacuum pumps, manifolds, instruments, etc.) should have current maintenance records. Be sure thermometers, HP gauges and vacuum gauges are strictly within their calibration interval.

Expiration Dates
We recommend that you avoid using expiration dates, if permissible in your state. The FDA is writing violations for distributors using expiration dates without a suitable stability study to justify the expiration date.

Definition of the Quality Control Unit (QCU)
If you are not using the industry standard GAWDA Medical Gas SOP Program, be sure your QCU is well defined. The responsibilities, authorities and membership of the QCU should be in writing.

Annual Records Review
Be sure you conduct an Annual Records Review. This is quick and easy to do.

Recommendation
We recommend that you carefully conduct a mock audit before the FDA arrives. If you would like Sample Mock Audit forms, Sample Annual Records Reviews, Sample Monthly Cleaning and Maintenance Inspection forms, please
contact me.

Gases and Welding Distributors Association
Thomas Badstubner GAWDA’s FDA & Medical Gases Consultant Thomas L. Badstubner is president of AsteRisk LLC in Blackstone, Massachusetts. Members can reach him at 508-883-0927 and tom@asteriskllc.com.