(Part 3 of 5)
The U.S. Food and Drug Administration (FDA) performs periodic inspections of food facilities in order to ensure the safety of the food that enters the U.S. After the FDA schedules an inspection, the FDA will send the company an inspection notice.
An FDA Notification of Inspection is a letter sent from the FDA advising the company that the FDA will perform an inspection of their food facility during a specified date. The FDA will propose a date range for the food facility inspection. The FDA requires the food facility inspection to be performed during the company’s normal operating hours so that personnel can be available to the FDA to provide information about the company’s operations and give FDA access to processing and production records. The inspection will be performed by one or more FDA investigators.
The FDA Food Facility Notification of Inspection requires a reply from the foreign food facility by the specified date indicating:
1. Whether the proposed dates for the food facility inspection are acceptable;
2. Contact name, telephone and fax numbers, and email address for a responsible person at the firm;
3. Mailing address for the company;
4. Address of any additional facilities that manufacture, process, pack or hold food intended for shipment to the U.S;
5. Whether an English-speaking staff member or translator will be present during the inspection.
It is crucial for a company to respond to the FDA by the date specified on the for or the FDA can refuse a product entry into the U.S.
As a result of the new Food Safety Modernization Act (FSMA) Reinspection Fees, the FDA has added a statement on the Food Facility Notification of Inspection advising whether a facility will be responsible for any costs incurred by FDA related to the inspection.
New statement for first inspections: “You will NOT be responsible for any costs incurred by USFDA related to this inspection.”
It is presumed that in the Notice of Reinspection the FDA will state the company’s responsibility for the charges. The cost for reinspections are $325/hour for overseas work and $225/hour for work performed in the U.S. The charge will be assessed after the inspection is performed.
The main goal of the food facility inspection is to establish whether the facility is operating in accordance with the Food, Drug and Cosmetic Act, regulations set forth in Title 21 of the U.S. Code of Federal Regulations that are applicable to the products produced in the facility, and other laws FDA enforces. It is through the food facility inspection that the FDA makes decisions on the food product’s admissibility when the food product is offered for importation into the U.S.
For questions related to U.S. FDA Foreign Food Facility inspections or any U.S. FDA regulation, please contact Registrar Corp 24/7 at https://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.