The U.S. Food and Drug Administration (FDA) announced they will raise the fee for re-inspections of applicable domestic and foreign food facilities and US importers for the Fiscal Year (FY) 2020. The fee for re-inspection of a foreign facility in FY 2020 will be $301/hr, an increase from $282/hr in FY 2019. The fee for re-inspection of a domestic facility in FY 2020 will be $258/hr, an increase from $253/hr in FY 2019. The new fees will be effective October 1, 2019 through September 30, 2020.
There is no fee for routine inspections, but if FDA finds significant violations related to food safety, they may conduct a re-inspection to ensure that appropriate corrective actions are taken to rectify the compliance issues. The Food Safety Modernization Act (FSMA) authorizes FDA to assess and collect hourly fees for re-inspections of non-compliant facilities to cover the cost of salary, travel, and anything else related to conducting the re-inspection. Each year, FDA estimates its costs related to re-inspections and adjusts for inflation and increased costs for the following year. These fees are assessed for any time spent on “whatever components of such an inspection are deemed necessary” and the final cost can easily climb into the thousands of dollars.
Inspections and Common Food Safety Violations
When registering your food facility with FDA, you consent to allowing FDA to conduct routine inspections of your facility for compliance with regulations. During these inspections, FDA assesses your facility’s compliance with Current Good Manufacturing Practices (cGMPs) and your Food Safety Plan, among other things.
At the conclusion of the inspection, if a compliance issue is found, the inspector will provide a Form 483, or a Notice of Inspectional Observations, to the facility. The facility is given 15 days to respond to the problems laid out in the Form 483. After review, FDA issues a final classification of compliance status. If “significant objectionable conditions” are found, FDA issues an Official Action Indicated (OAI) classification. This can lead to regulatory action and in cases of the issues being directly tied to physical food safety, a re-inspection may occur. Non-material food safety requirements, such as having non-compliant labels would not require a re-inspection.
Common food safety violations include not properly excluding pests, not establishing appropriate controls for food hazards, not maintaining cleanliness in a facility, and having issues related to personnel. FDA is issuing a growing number of citations relating to Food Safety Plans since a reasonable amount of time has passed since the deadlines for most food facilities. FDA will also re-inspect juice and seafood facilities with HACCP plans or dietary supplement facilities with significant violations. With the fees for re-inspections increasing, it has only become more critical to be compliant with FDA food safety requirements and be prepared for an inspection when the time comes. FDA can also issue regulatory action such as warning letters, detentions, and suspensions of registration for infractions, causing further delays and costs.
Registrar Corp is a private company that assists businesses in complying with FDA regulations. We can help your facility prepare for an FDA inspection with our Mock Inspection service as well as assist your facility in developing a HARPC food safety plan or a HACCP food safety plan to avoid citations. For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.