Understanding the Differences Between Audits and Inspections: Do the Addresses Match?

Let’s begin with the end in mind: if your food facility is registered with the FDA and you want the agency to consider your third-party food safety audits, make sure the FDA can readily verify that the facility was indeed audited. Check that the address associated with the audit matches the address on your FDA food facility registration number.

Market access audits (e.g., 2nd and 3rd party) are no substitute for regulatory inspections (state, federal); they are not interchangeable. And I’m not suggesting that the FDA should ever shirk its oversight and enforcement responsibility. But since both inspections and audits seek to verify food safety systems, there should be a relationship between them, especially in this time of limited resources and desire for more transparency:

• Not enough FDA inspectors (or budget) to meet FSMA’s mandates

• Company staff time spent on audits and inspections

• Annual audits

Audits are imperfect and don’t guarantee that a facility won’t have a food safety issue. The same can be said for regulatory inspections. However, limited resources require people to make difficult decisions. And sometimes, we can also find creative (or even obvious!) solutions.  If a company has “100 units” of food safety capacity, how many units should be spent on handling an audit compared to solving food safety risks? If the FDA has “100 units” of food safety capacity, how many units should be spent inspecting a facility that just had a reputable 3rd party audit versus spending on facilities that are completely unknown?

I’m encouraged that many stakeholders are interested in exploring how we can work better together, examining the totality of resources, and figuring out how they can be allocated in a way that is best for food safety and public health.

But let’s get down to brass tacks. Say that the FDA was willing to consider that an FDA-registered facility was also subject to routine 3rd party food safety audits. How would FDA be able to marry up their list of registered facilities with the list of facilities known to have been audited (SQF, FSSC22000, and BRC all maintain lists of facilities with legitimate audit certificates)? You’d think they could match up addresses, but based on a recent conversation with the Agency, they often don’t match!

Until recently, the FDA’s inspections of foreign facilities were pre-announced because the agency did not want to risk showing up at a location that was no longer operational. Suppose that the facility recently underwent a 3rd party audit. Could the FDA be confident that the facility existed, show up unannounced, and conduct the inspection more similarly to US facilities? (I’m not sure if 3rd party audits are being used by FDA in this way now, and if it relates at all to their shift to unannounced foreign facility inspections.)

Deeper conversations around how the FDA can view and consider audit findings are warranted. Would facility-specific audit findings help focus an FDA inspection, or bias it? Can trends around “problem areas” help FDA and others develop more education and training resources? This would likely require more active engagement of individual firms. Today, with the accessibility of audit certificates, the FDA can theoretically get going and start using this information, as long as the addresses match.