Top Five FDA Violations

The FDA continues its inspections of medical gas companies. It is true that there are far fewer compliance actions resulting from the FDA inspections. The reduction in compliance actions is due to three major factors:

  1. Improved compliance among the medical gas producers
  2. Centralization of warning letter approval within the FDA
  3. FDA’s emphasis on other industries (seafood, mammogram providers, etc.).

However, recently there have been some notable, and painful, FDA inspections. In the mock inspections provided by AsteRisk, we sometimes find items that are overlooked by medical gas companies.

Top Five Items Mentioned in Warning Letters
This list of the top five violations is summarized from the last five years of FDA warning letters and the type of items found during mock audits. Take a quick look at these items and see if they could be found in your company.

Violation # 1 Failure to establish scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. 21 CFR 211.160(b)

Action Item Check your analytical procedures. Do you have written procedures for operation of the Servomex Oxygen Analyzer (and other test methods) and the use of calibration standards?

Violation # 2 Failure to establish adequate written procedures for production and process control designed to assure drug products have the identity, strength, quality and purity they purport or are represented to possess. 211.100(a)

Action Item Check your production procedures. Do you have written procedures for filling the cylinders/containers and for quarantine/distribution?

Violation # 3 Failure to assure each employee engaged in the manufacture, processing and holding of medical gases has the education, training and experience required to perform their assigned duties. 211.25(a)

Action Item Check your training program. Do you have training records for your employees about Current Good Manufacturing Procedures, quality control, SOPs, cylinder filling operations, distribution, record keeping and traceability?

Violation # 4 Failure to routinely calibrate automatic or mechanical equipment according to a written program. 211.68(a)

Action Item Check your calibration program. Do you have calibration records for the high pressure gauges, vacuum gauges, thermometers, Servomex, etc.?

Violation # 5 Batch production records for drug products are not reviewed and approved by a quality control unit prior to release of the products. Failure of the quality control unit to conduct an adequate investigation of any unexplained discrepancy or process failure. 211.192

Action Item Check your production records. Are they correct, signed and dated by the filler/tester/QCU?

The good news is that by following the GAWDA Medical Gas Program, you will be protected from these potential violations.

The FDA’s draft guidance for medical gases was issued in 2003. We know that someday the FDA will issue the final guidance. When they issue the final guidance, it is possible that there will be a renewed emphasis on FDA inspections in our plants. Now is the time to prepare by putting your company into compliance. Take a critical look at the five action items above and see if you have room for improvement.

Gases and Welding Distributors Association
Meet the Author
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 or at