Handling Extreme FDA Inspections

The FDA regularly inspects GAWDA members for compliance with food, drug and device regulations. Most of these inspections are routine and reasonable. However, there are a few inspections each year that become very difficult…even adversarial. In the past year, these difficult inspections have occurred at GAWDA members with exemplary compliance programs.

For example:

  • In one case, the FDA investigator required the firm to use expiration dates. This is clearly contrary to current agency thinking for medical gases. (We should not be using expiration dates on medical gases.) The expiration date violation was overturned when the issue was escalated to FDA headquarters. Sometimes state agencies are also confused about the FDA’s current position on expiration dates.
  • In a couple of cases, the FDA has issued violations for the use of leak testing solution. There have been no problems that we are aware of with leak testing solutions. However, the solutions have ingredients and labels that concerned the investigator.
  • We have seen recent violations regarding the qualification of battery-operated drills for closing “Medical E” style post valves. This is a very low risk issue. Battery-operated drills and air wrenches operate the valves consistently and offer personnel safety benefits. If you would like additional information about qualification of valve operating wrenches/drills, contact me.

These unusual and creative violations are not commonplace. They illustrate the discretionary authority given to investigators. If you become subject to unusual FDA practices or interpretations, please advise me so we can help provide a unified approach to responding to the inspection. In extreme cases, we have found solid support from the Compressed Gas Association (CGA) to help promote safe and compliant practices.

The FDA recently issued Draft “Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.” We are not aware of any GAWDA members who have impeded the FDA’s right to inspect our facilities. However, there have been some inspectors who have made demands that members were unprepared to accommodate.

For example:

Affidavits – Occasionally, an FDA investigator requires the plant personnel to sign an affidavit. If you are asked to sign an affidavit, we recommend you contact your legal counsel before proceeding.

Customer Lists – An FDA investigator may sometimes ask for customer lists. Many companies consider this to be highly confidential information. We recommend that you seek clarification from the agency before releasing sensitive customer information.

Business Hours – An investigator has the right to inspect the facility during reasonable business hours. There have been perceived unreasonable requests to inspect after hours or during normal lunch periods. Be aware that you must cooperate with the inspection, but you should not be subjected to unreasonable requests.

Personnel – Sometimes an investigator may object to certain personnel being present during the investigation. You have the right to decide who from your company will be present during the inspection. For example, you might have compliance specialists from your company in attendance to help answer questions and provide support. However, be aware that if you delay an inspection in order to assemble appropriate personnel, the agency will take this seriously and could react negatively.

Most inspections are fairly routine, though seldom pleasant. If you are experiencing a difficult inspection or feel that you are being treated harshly, please contact me. Contacting GAWDA consultants is a free benefit of your membership. We may be able to offer assistance to help endure a difficult inspection. We can also assist in the post-inspection responses to the agency.

Gases and Welding Distributors Association
Thomas Badstubner 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 and tom@asteriskllc.com.