FDA: Exporting sterilized products to the United States

Exporting sterilized products to the United States

Are you ready to conquer the American market? Perfect, but do you know that you will have to face the FDA (Food and Drug Administration). All exporters to the USA will tell you: getting it approval is a real obstacle course! In this article, we guide you through the role of the FDA, its requirements and the different steps to obtain accreditation.

The FDA and its role in exporting to the USA

The US Food and Drug Agency regulates all vegetable-based foods, as well as additives, preservatives and food colorants. FDA is also in charge of soft drinks. It operates as part of a rigorous approach to ensure the health quality of products entering the United States.

To export beverage or food specialties to the country, it is imperative to comply with the strict standards set by this agency. All goods must have an identification number. It is a mandatory step to be put on the market. The law requires compliance with the quality criteria established by the FDA and any deviation from these standards may be a point of non-compliance that may lead to an export refusal. The agency verifies the compliance of food and beverage products with established standards, thus ensuring a high level of safety and quality for American consumers.

FDA: Exporting canned goods to the USA

  1. The company wishing to export must create an FDA account, register as a food production facility (FFR – Food Facility Registration), and identify this site as a producer of acidified or low-acid canned foods (AF/LACF – Acidified Food/Low Acid Canned Food). These steps are essential to later access the online registration system for AF/LACF products.
  2. The company must register as a FCE (food canning establishment) with the FDA, with the Form 2541 to be completed online. A “contact” person (FCP-Facility Contact Person) must be designated and registered in this form. This is the contact person for the FDA to whom the agency will address any question. This person must therefore be a stable person in the company, often one of the leaders.
  3. Company must obtain pre-arrival: SID – Submission IDentifier procedure. This procedure analyzes the product sterilization process, which must be documented and submitted to the FDA as a “process filing”. Each product is assigned a “SID” file giving it a specific identification number.
  4. Records for each product are completed online using the AF/LACF Electronic Registration System Form 2541d. The person declared as a FCP may authorize one or more persons to access his account via the registration system to complete the “process filings” files
  5. For each SID file, product & process information must be summarized in a single document called “scheduled process”.
    The main information to be reported are:
    • Packaging type and dimensions,
    • The mode of operation of the autoclave,
    • Step up time, temperature and step down time parameters to obtain the desired minimum F0,
    • Critical factors that could affect heat transfer in the product.

To this document, must be attached validation reports (temperature distribution studies, heat penetration studies, datasheets…)

All these documents give confidence to the FDA approver on the control of the process.


FDA: Steriflow supports you

Steriflow has a long-standing partnership with the American consultant Phf in order to ensure that validations are made to the specifications required by the FDA.
On-site validation of autoclaves and products is carried out by our engineers. As for the technical file, it is written by us with the help of the consultant Phf. The latter can also serve as an agent for the registration of different production sites.

Steriflow guarantees your FDA approval!


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