The FDA and National Association of State Departments of Agriculture (NASDA) and our state partners have collaborated to develop two new documents to be used in support of produce inspections.
Form 4056 (Produce Farm Inspection Observations)
The first document is the Form FDA 4056, “Produce Farm Inspection Observations.” This form represents a new way of providing feedback to farms and documenting observations that is different from FDA's traditional process of reporting observations made during an inspection, which has historically been through the FDA 483 Inspectional Observations Form. The new form (FDA 4056) is designed around the specific provisions in the Produce Safety Rule and was developed to help farmers better understand what is being examined in an inspection. FDA will issue the new 4056 form at the end of every farm inspection, whether or not any non-compliance issues were identified, to help farmers understand what is being examined in an inspection and how any observation relates to the regulation. FDA is working with states to promote consistency among inspections through use of the new form.
Dispute Mitigation and Resolution
For the produce inspections being conducted by FDA, the agency has developed a Dispute Mitigation and Resolution procedure, which is formalized as Field Management Directive 152. This provides a process for resolving differences between FDA and state regulatory authorities during inspections.