Up Front

Calls come in several times a week from food processors asking questions about a recent audit or inspection. These may be about customer audits, GFSI, or third-party food safety audits from one of the many providers that offer them to our industry. These calls often concern a finding or interpretation of a specific issue with questions about how to react to it or correct it. Most recently we have a seen an increased number of questions regarding recent or active FDA inspections.

Many of these questions are about the changes taking place with the Food Safety Modernization Act (FSMA) legislation regarding inspections, particularly FDA's focus and increased authority. But several have been around receiving a Form 483 as a result of findings during an inspection. Many of the 483s have not been very pretty. So the question to ask is, has FDA established a new focus and energy performing more detailed inspections…or has our industry slipped?

For several years, I believe the FDA's attention was drawn away from inspections and becoming more reactionary and focused on budget restraints and the many new responsibilities the agency continued to get assigned. I suspect the new FSMA legislation and the attention and energy from all of the recent activities have refocused FDA's regulatory efforts to more focused and detailed inspections. From some of the 483s shared with us, it seems like FDA is becoming more active and more detailed while in food facilities.

While I don't think our industry has slipped, the increased focus on program development and documentation may have taken resources away from the everyday operational activities on the factory floor. I am concerned that many food facilities are not as ready for the detailed inspection that FDA seems to have renewed.

Many of the "observations noted" on the Form 483s that I have reviewed are due to the failure of basic GMP and prerequisite programs. They are not due to new FDA initiatives nor do they need a rocket-science solution.

Another observation is that facilities often do not understand the need to respond to FDA about proper corrective actions. For example, FDA does not want to know that you cleaned a specific piece of equipment that was found in unsatisfactory condition at the time of the inspection. They want to understand that the facility has developed programs to ensure the issue won't occur again.

While I have to believe our industry continues to improve through more developed programs and process controls, I am concerned that we have forgotten the disciplines of self-inspection, daily operational controls, and the basic GMPs needed to create a safe production environment.

Like FDA, I think the industry as a whole needs to refocus our energy to detail, self-inspections, and daily operational issues. We need to validate our programs and processes every day. It appears that FDA has a renewed focus toward on-the-floor inspections. We need to be prepared.

The author is Vice President of Food Safety Education, AIB International.