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Food & Bev

Are You Prepared for an FDA Audit?

Grainger Editorial Staff

It’s sure to happen eventually: an FDA inspector will visit your facility. According to the Department of Health and Human Services, approximately one in every five food and beverage manufacturers will undergo an inspection in any given year, so you can be sure your turn is coming. How will you know if you’re prepared for an FDA audit?

Constant vigilance is needed be ready for an FDA inspection. If your facility treats every day like inspection day, then it will be business as usual when the auditor finally arrives. Hoping the inspector won’t look under the rug is not a strategy—they have far more experience spotting food safety issues than you have trying to hide them. And with the power to order immediate corrective action and disciplinary measures, the inspector’s findings can carry severe consequences.

How Does the FDA Choose Which Facilities to Audit?

FDA audits can take place for several reasons: your facility might be randomly selected, or the inspector may be following up to ensure problems from the past have been corrected. They may also be investigating the source of a contamination incident, or responding to a safety complaint. Whatever the reason behind the inspection, nothing is off limits: expect every zone of production to be visited. Samples may be collected from any stage of processing, and past safety records will be reviewed. Since the inspection can happen at any time, you need to be preparing all the time.

FDA Audit Checklist: Five Keys to Acing Your Audit

To pass an inspection, your facility's FSMA Qualified Individual--the employee responsible for developing and implementing your food safety plan--needs to bring the mindset of an inspector to work every day. Every facility will have a unique plan that addresses its combination of hazards and critical control points, but five general strategies can help ensure you are on the right path:

  • Know the Script The FDA publishes detailed inspection guides: your Qualified Individual should know these instructions by heart. The instructions will tell you which systems and procedures are sure to be examined, as well as which areas of the production line are sure to be sampled.Inspectors have broad latitude to use their judgement, but in many areas, they will be looking directly to sections of CFR title 21, which codifies current Good Manufacturing Processes for high-risk ingredients like eggs, milk, and meat.
  • Showcase Solutions The inspector isn’t just looking for unsanitary conditions on the production floor. They are also going to verify that your facility has hazard controls in place to address potential trouble points. For example, if your facility uses milk, the FDA inspector will not just check the current temperature of your holding tank—they will be equally interested in the procedures you have implemented to verify the refrigeration system is maintaining a stable temperature.
  • Keep Your Records Straight The condition of your bookkeeping is almost as important as the conditions on the production floor. The inspectors may want to examine logbooks from any point in the past—if the logs are illegible or misplaced, it’s going to raise questions about how carefully your facility’s critical control points are being monitored.The FDA inspectors will be particularly interested in how you have responded to past incidents. You need to be able to demonstrate that you’ve taken corrective action following safety lapses, and that means keeping thorough records of employee retraining and changes in procedure.
  • Look Upstream (and Down) Your Qualified Individual’s daily routine is likely focused on the most critical points of production, such as maintaining sanitation in post kill-stage processing. But you cannot let your upstream and downstream operations become an afterthought. Inspectors will be reviewing every stage of production and every zone of your facility, from the moment ingredient deliveries arrive at the gate until the packaged product leaves the loading dock.
  • It’s Not What You See, It’s How You Know Finally, your Qualified Individual needs to be sure they can demonstrate the validation and verification regime for every hazard control. The inspectors need to be assured that confidence in your safety plan is warranted. This means being meticulous about record-keeping and double-checking the accuracy of your instruments. Remember, inspectors aren’t just looking at what’s happening right now—they’re interested in whether your controls are capable of addressing issues before they threaten the food supply.

It's not a matter of if you'll be visited by the FDA, it's when, so staying on top of the correct daily routines is crucial. If you treat every day like it's the day the FDA is visiting, you won't have anything to worry about when they do.

The information contained in this article is intended for general information purposes only and is based on information available as of the initial date of publication. No representation is made that the information or references are complete or remain current. This article is not a substitute for review of current applicable government regulations, industry standards, or other standards specific to your business and/or activities and should not be construed as legal advice or opinion. Readers with specific questions should refer to the applicable standards or consult with an attorney.


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