What to Expect During a Produce Safety Regulatory Inspection

The GDA Produce Safety Program makes routine produce inspections every year. They’re required and are different from yearly third-party audits. For example, they could be follow-up or for-cause inspections to verify corrective actions have been taken. Inspections are an integral part of the GDA’s commitment to safety, education, outreach, and technical assistance to farmers and producers around the state.

This is an overview of the steps that state or federal inspectors may take during a routine Food Safety Modernization Act (FSMA) Produce Safety Rule (PSR) inspection, and should address any questions that you may have. If you have more questions, please contact the GDA Produce Safety Program at 229-386-3488.

Scheduling the Inspection

If you’re the designated owner or manager, you’ll be contacted to schedule an inspection. You’ll serve as the main point of contact, and you should work closely with the inspectors to schedule and support the completion of the inspection.

Pre-Inspection Call

During a pre-inspection call, the inspector will ask you some questions to decide whether the PSR applies to your farm. The inspector will formally introduce themself, explain the reason for contact, and provide a high-level overview of the goals and purpose of the routine PSR on-farm inspection. For more information, please use the FDA decision tree.

During the call, the inspector will discuss topics including:

  • Farm size (produce and/or food sales), to determine if the farm is subject to the rule or meets the requirements for a qualified exemption;
  • Whether the farm grows produce covered under the PSR;
  • Whether the farm conducts activities covered under the PSR (e.g., growing, harvesting, packing or holding produce), or meets the requirements for a processing exemption;
  • If the farm is growing one or more “priority produce commodities” (if so, the inspection will focus on those types of priority produce);
  • Determine if your farm has more than one growing season and what those timelines generally look like.

If the farm is determined to be exempt or qualified exempt, the inspector may schedule a time to perform an exemption verification to review records that support the farm’s status. 

Who Should Participate?

The farm owner, person in charge (PIC), and/or produce safety manager should be available and on-site during the inspection. These people are encouraged to take part in the inspection process.

A person from the farm who knows about the growing, harvesting, packing and holding activities (preferably the person responsible for produce safety) should accompany the inspector to provide the details about the farm’s operations and practices.

Announced Inspections

After the pre-inspection call, if the produce grown on the farm is covered by the rule, the inspector will schedule an inspection date. The inspector and PIC should discuss any farm biosecurity practices, hazards, safety protocols, and other requirements before the visit.

In most cases, the inspection will be scheduled within five (5) business days after the initial contact. If the PIC is not the produce safety/quality expert, such a person needs to be present during the inspection. It’s crucial that your representative knows about your operation’s growing, harvesting, packing, and holding activities.

Upon arrival, the inspector will explain the general flow of the inspection, what the inspection will cover, and what records may be reviewed.

Unannounced Inspections

Most inspections will be announced. However, some unannounced inspections may occur for the following reasons:

  1. If the farm is unresponsive (no contact within five (5) business days after reasonable contact attempts have been made), or unwilling to set a reasonable date for the inspection; in these cases a refusal letter will be mailed or hand-delivered to the farm.
  2. If the farm has had produce safety issues in the past and the issue has not been corrected within established timeframes.
  3. If a follow-up inspection is needed and an unannounced inspection is necessary to observe the corrective actions/changes being made.
  4. If the inspector is responding to a complaint, recall event, or foodborne illness outbreak investigation.

The Day of the Inspection

When an inspector arrives on your farm, they’ll ask to speak to the owner or PIC. The inspector will introduce themselves (name, title, agency), show the farm staff their official identification/credentials, and announce the reason for the visit. A written “Notice of Inspection” or similar document may be provided to the farm, depending on any state regulations or if the FDA is conducting the inspection.

Initial Interview

The inspector will provide a brief description of the justification and scope of the inspection, and the activities they will be conducting during the visit. The amount of time an inspection takes varies; it depends on the type of inspection, farm activities, size of the farm, and what’s observed during the inspection. The inspector will also discuss the farm’s organization and any specific activities performed at the farm on the day(s) of the inspection such as planting, harvesting, packing, or holding.

Walk-Through During the Inspection of the Farm

During the inspection, the inspector will observe farm operations, working with the owner to coordinate the timing of the inspection in order to view various aspects of farm operations. An inspector may also ask questions about farming practices and operations which they’re not able to observe during the inspection.

Throughout the inspection, the inspector will explain what is being looked at and why. If there are any regulatory concerns, the inspector will discuss them with the PIC and explain the reason(s) for each regulatory concern and its public health significance.

Inspectors will take notes and may take photos and collect samples. They’ll also review and may copy records.

Exit Interview

The exit interview will ideally occur with the PIC, farm owner, manager, and/or produce safety manager. The inspector will go over any regulatory concerns and findings, and will provide information on resources and technical assistance.

If the PIC is able to make corrections during the inspection, the inspector will document them immediately on-site. If the deficiency cannot be corrected during the inspection, the inspector will work with the owner or manager to determine a reasonable timeframe to take preventive measures and corrective actions.

During the exit interview, the inspector will also identify preventive produce safety practices and conditions on your farm that align with the requirements of the PSR. They’ll answer any questions you may have about the inspection. They’ll also provide the owner or manager with an inspection sheet and agency contact information that documents everything they noted during the inspection. If any follow-up inspection is required, they’ll explain the process.

Throughout the year, your inspector should serve as a resource for you. They’re here to help. Feel free to contact them or the GDA Produce Safety Program’s main line if you have questions, changes in operation that could need a re-inspection, or other issues that the GDA can support.

Funding for this program, statement, publication, press release, etc. was made possible, in part, by the Food and Drug Administration through grant PAR-16-137. The views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of tradenames, commercial practices, or organization imply endorsement by the United States Government.

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