The FDA may assess fees under Section 107 of the FSMA whenever the FDA, or its agent, inspects a domestic or foreign facility and the final classification of the facility is:
1. Official Action Indicated, and
2. The non-compliance was “materially related to food safety.”
The fee will be assessed for a reinspection of domestic and foreign facilities to determine whether corrective actions have been implemented and are effective and compliance has been achieved to FDA’s satisfaction.
What does the FDA mean by: “reinspection”?
Domestic Facilities: Reinspection means one or more inspections conducted under the FD&C Act subsequent to an inspection that resulted in a final classification of a facility as OAI and where the non-compliance was materially related to food safety.
Foreign Facilities: Reinspection means one or more inspections conducted by officers or employees duly designated by the Secretary subsequent to an inspection which identified non-compliance materially related to a food safety requirement under the FD&C Act.
What does the FDA mean by: “materially related to food safety”?
Some examples of non-compliant conditions or practices that “materially relate to food safety” include, but are not limited to:
- Food borne pathogens in ready to eat products
- Pesticide residues on food or feed products above established tolerances
- Failure to declare the presence of a major food allergen in product labels
- Lack of adequate hazard controls (HACCP)
Who Pays the Facility Reinspection Fees?
The party responsible for paying the Facility Reinspection Fees include:
- The responsible party for a domestic facility
- TheU.S.agent for a foreign facility
- Each importer subject to reinspection
How much will a reinspection fee cost my company?
Rates: For Fiscal Year 2012, the hourly rate per FDA inspector participating in a reinspection is $224.00 per hour if no foreign travel is required and $325.00 per hour if foreign travel is required.
Number of FDA employees or agents assigned to a reinspection: The FDA will make this determination on a case-by-case basis. Relevant factors for this decision include the size of the firm, number of products, number and nature of the violations observed in the initial inspection and the amount of expected resources needed to evaluate the firm’s corrective actions and current state of compliance with respect to the items identified in the initial inspection.
Billable Activities: conducting the reinspection at the facility, making preparations and arrangements for the reinspection, traveling to and from the facility, analyzing records, analyzing samples, preparing reports or examining labels and performing any other activity deemed necessary to determine compliance with the regulation or statute found to be violated in the initial inspection.