When a food facility registers with FDA, it grants FDA permission to inspect the facility at any given time. Initial FDA food facility inspections are of no cost to the facility and may occur due to routine reasons, a facility’s level of potential risk to public health, or as a response to a problem or complaint.
If FDA discovers certain food safety violations during an initial inspection, the Agency may decide it needs to return at a later date to evaluate whether the facility implemented appropriate corrective actions. This second evaluation is considered a reinspection (also sometimes referred to as a “compliance follow-up inspection”).
The frequency at which initial FDA inspections occur may continue to increase in response to mandates under the 2011 Food Safety Modernization Act (FSMA). FSMA directs FDA to inspect domestic facilities at a rate determined by the risk its products pose to public health. High-risk facilities are to be inspected every three years, while low-risk facilities are to be inspected every five years. FSMA also directed FDA to increase its annual inspection of foreign facilities. FDA provides foreign facilities with notice that an inspection of the facility will occur. Domestic facilities may receive no notice at all. Regardless, it is crucial for all facilities to take steps to be prepared for the initial FDA inspection at all times.
