Surviving an FDA Inspection

Category: Regulatory
Published Date Written by Keith Harasyn

Editor's Note: This article originally appeared in the October 2011 Newsletter. It is reprinted as part of our archive article series.

Surviving an FDA Inspection

Keith Harasynby Keith Harasyn, ASQ-London 0403 Chair

The US Food and Drug Administration (FDA) has a mandate to protect American citizens from unsafe food, drugs, and medical devices, and to promote safe practices with regards to health.If you work for a Canadian company manufacturing medical devices or pharmaceuticals you already deal with Health Canada regulations, such as applying for a medical device license for level 2, 3, or 4 devices, or a medical establishment license for a level 1 device.Why would you care about US regulations?The obvious reason you care about the FDA is if your company exports product to the US market.Unlike in the United States however, where the FDA can shut down a facility they discover is manufacturing unsafe products, in Canada, the FDA’s jurisdiction stops at the border; where they are limited to banning imports into the US.How this affects you depends on how integrated the US market is to your business plan.Most companies can not afford to ignore our largest trading partner.

Getting the call

In the last year or so , the FDA has hired approximately 60 new Inspectors and increased its surveillance of foreign manufactures.What this means is that Canadian companies are more likely to be inspected.If your company is part of multinational firm, it's most likely that the FDA officer will contact your US based Director of Quality or the CEO.Independent Canadian companies will usually be contacted through the Quality Manager or other Management representative.With Canadian inspections, the FDA will give notice of when they would like to conduct the inspection, and usually this will include some alternate dates about 2 to 3 months in advance.You may have heard of horror stories of the FDA leaving notice on a voice-mail at 4:55 on a Friday afternoon then showing up at 8:00 am Monday morning.For the most part, this type of incident is isolated to the United States, where enforcement is part of the FDA mandate.

What to do after getting the call

Once the details are agreed upon, you will need to begin planning for the inspection.In 2008, Health Canada mandated that all medical device manufactures at level 2 or higher must be registered to ISO 13485 – the ISO medical device standard.ISO 13485:2003 is closely based on ISO 9001:2000.That is, the sections are organized around processes: 4-Quality Management System, 5-Management responsibility, 6-Resource management, 7-Product realization, and 8-Measurement, analysis and improvement with some additional requirements specific to medical devices.This is in contrast to the FDA standard 21CFR820, which is loosely based on the 1994 version of ISO 9001.Those of us who've been in the quality profession for more than 15 years will remember the “20 sections” of ISO 9001:94.With a greater emphasis on inspection and less emphasis on improvement, in some ways the 1994 edition seemed arbitrary and the categories unrelated to the bigger picture ofthe Plan-Do-Check-Act cycle.As a result, an FDA inspection has very little to do with improvement and much more to do with compliance.For instance, is your incoming inspection controlled?In this day and age, with tightsupply chains and efficient product qualification, receiving inspection in most companies is minimal at best.Be aware that a system compliant to ISO 13485 or ISO 9001 may not meet FDA 21CFR820 requirements.Assembling an experienced team and performing a gap analysis to the 21CFR820 standard should be your first step.

Use outside help when necessary

Your internal team may have little or no experience with the FDA.This is good reason to look for outside help.We all know our own system and usually we know our ISO auditors quite well, so we get comfortable with audits and can anticipate expected outcome.FDA inspections, on the other hand, are less frequent and unfamiliar.It is unlikely that you will know the FDA Inspector and how they operate, so having a trusted information source, whether they're from your corporate office or a consultant can be invaluable.This should give you a feel for what you can expect during the inspection and a plan to address your weaknesses prior to the inspection.

Prepare for the inspection day

Once you know your company's weaknesses, assign actions to correct these issues and schedule time for follow-up.Many quality tools can help with problem solving and analysis.Leave plenty of time for your personnel and Operators to be familiar with any new requirements that are introduced to your processes.Ensure training is complete, procedures updated, and any outstanding issues found in the gap analysis are closed.During audit preparation, it always seems as though the little things take up a disproportionate amount of time and effort.Last but not least, as in any other audit or inspection, walk the floor beforehand and ensure the plant is clean and presentable.This is what the Inspector will see and first impressions are always important.

Deal with the outcome

It is unusual not to have a findings after an FDA Inspection.If there is a finding after an on-site inspection, the FDA Inspector will issue a “form 483 – Notice of Inspectional Observation”.The observations listed in the form 483 are the inspector's interpretation of the regulations as they pertain toyour quality system.The field inspector will submit the form 483 to his or her supervisor, after which the FDA may issue an FDA Warning Letter to your firm, depending on the severity of the findings.Either way, you must respond to the form 483 promptly, and identify the course of action you are taking to address the finding.The FDA will specify the time-frame for this action to occur.A detailed response for each item identified in the 483 is also required.Hopefully, the FDA will have no findings or only minor findings.Once these are addressed, you will have a compliant system with one additional bonus: you will have the experience of surviving an FDA Inspection.