The FDA Investigator Is At The Door

For GAWDA members, it may have been a long time since the FDA conducted an inspection. Improved safety of medical gases has likely contributed to the reduced frequency of inspections. There has been, however, an increase in the number of inspections in 2010. You can effectively control your compliance destiny with a Comprehensive Inspection Strategy.

Preplanning – Maximize Compliance
Ensure compliance before inspection. Create a plan for compliance and execute it. Your plan should include the following:

Prior Inspections – The FDA has your history. They expect that prior inspectional observations are permanently corrected. Repeating violations can result in severe action.

Well-Written Procedures – The regulations require written procedures that are followed. The GAWDA Medical Gas Program has outstanding written procedures.

Training – The FDA requires that personnel who handle medical gases are trained in Current Good Manufacturing Practices annually. GAWDA has cost-effective training to meet this requirement. Medical gas personnel must have documented training and qualifications for their job functions.

Calibrations – Ensure that Servomex, gauges, thermometers, scales, etc. are in calibration and a record is on file.

Records – Ensure each fill log is properly completed and that the Quality Control Unit (QCU) release the product before the product is moved out of quarantine. In mock FDA inspections, this has been the largest compliance issue.

Professional Conduct – Minimize Exposure
There are some actions you can take during the inspection to improve the inspection outcome.

Credentials – When the inspector arrives, review his or her credentials. Ask the reason for the inspection.

Work Space – Take the investigator to a suitable area (e.g. conference room). Be sure the FDA records are not in the room. When the investigator asks for records, bring them. Escort the inspector at all times (e.g. plant tour).

Honesty – If the inspector asks you a difficult question, respond honestly. Do not volunteer additional information. If you are uncertain how to respond, tell the investigator you will get the answer.

Copies/Photos – The investigator may take photos of the work area or make copies of compliance records. Take duplicate photos and make duplicate copies for yourself of any records the investigator requests. If you have a proprietary process or records, consult with your attorney about how to keep copies confidential.

Internal Audits – Normally, the inspector will not request copies of internal audits or mock inspections. These are confidential records and should not be shown. The inspector may ask for proof of an annual record review. Provide proof of this action without disclosing the results. If you are filling device gases, there are other reports the inspector may request.

Clarify – The inspector might misunderstand our vocabulary or misinterpret the agency’s own enforcement discretion. Seek to have any misunderstandings corrected before the Form 483 is delivered. For immediate assistance, call me or send an e-mail with “911 FDA” in the subject line.

Post Inspection Actions – Manage the Response
After-inspection response is critical.

Timely Written Response – Respond to a Form 483 or equivalent inspectional observations within 14 days. This is important if the inspection could lead to further agency action. Your response details each finding, your perception of the issue and an action plan for correction. The FDA is not obligated to consider your responses after two weeks.

Evidence of Completion – Written response must include proof that the issue has been corrected. The agency may reject statements by the firm that the issue is complete unless actual proof has also been submitted, like cGMP training records. Demonstrate to the agency that you are in full compliance. You would like them to consider you a low priority for a follow-up inspection.

Effective Corrections – In the case that you receive inspectional observations and subsequently correct them, be absolutely certain that those items never recur so they do not escalate beyond a Form 483. If the agency issues a Warning Letter or conducts a seizure, the results are published on the Internet for all to see.

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