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Our specialized advice on the FDA procedures goes far beyond simply filling out the forms required to export food products into the United States, as it also includes reviewing critical elements of the manufacturing processes, reviewing supporting documentation, such as Health Authority [ASL] certificates and the request for import permits
We are talking about a complex and in-depth technical consultancy work concerning the import of food products, which are highly specialized on procedures for export to the United States of America We have obtained the FDA certifications for important multinational food products companies and for several leading Italian companies producing a range of products, to include canned tuna, mixes for the preparation of ice creams, ready meals, cheese creams, preserves, and truffle and truffle creams. All these companies are now exporting and selling their food products to the United States with great satisfaction.
The class of foods that include canned, vacuum-packed or pickled products such as tuna, peeled tomatoes, jams or sauces, requires an analysis procedure and prior approval of the production processes by the FDA for import and marketing into the United States of America.
The FCE registration and SID procedure are the only two FDA requirements that precede the import into and sale in the US. For other products, the FDA limits itself to providing the regulations and then inspecting, during the import procedure in the US, that the shipment complies with them.
The control of the production process for the aforementioned product classes is related to the risk of botulism which, in the absence of oxygen at acidity levels above a pH of 4.6, is very high.
In such cases, the Food and Drug Administration requires the manufacturing company to register and obtain the so-called FCE number [Food Canning Establishment] and, for each class of product, certification of the production process. The certification is also supported by the issuance of a so-called SID number.
Therefore, while the FCE registration number belongs to the company, the SID number is typical of the product family that is certified. Central element for the issuance of the SID certification is the validation of the autoclave [autoclaves] used to sterilize the product in question [preserves, ready sauces, jams, peeled tomatoes, mushrooms or truffles, cream cheese, etc.]
The validation of the autoclave and the sterilization process is a documentary step that is completed by exchanging information online concerning the production and sterilization process between the manufacturing company that intends to export to the United States and the FDA process specialists.
In fact, a productive relationship is established between the company requesting the SID number and the FDA technicians. During this process, the company provides information relating to the type of autoclave and the sterilization and production process used. After receiving such information, the FDA technicians may determine whether additional information is required, usually extremely technical, in order to ensure the adequacy of the sterilization of the food product that the company wished to export to and sell in the US.
The work at hand, therefore, goes far beyond the simple uploading of data to an electronic form; we provide specialized consultancy on the autoclave validation processes and on the SID procedure required by the FDA. This process requires engaging the FDA officials specialized in food preparation techniques at a very technical level. The type of requests, among other things, is not necessarily determined by a strict protocol; indeed, the FDA officials actually ask for the most disparate information, all aimed at ensuring that the food meets the sterility requirement during the entire production process.
Many of ExportUSA's competitors quote prices for assisting with the SID procedure that are much lower than those charged by ExportUSA. However, there is a basic misunderstanding: the work of our ìlow-costî competitors is limited to filling in the online forms and does not deal with the validation of autoclaves or the effectiveness of the production process, which are essential to guarantee the sterility of the food product to be imported into the US.
ExportUSA relies upon an in-house technician who, over the years, has honed valuable expertise in food preparation techniques. Our FDA consulting service is well-rounded and covers all aspects involved in SID certification. Our work goes far beyond simply completing and submitting an online form.
ExportUSA takes care of ensuring that your products adhere to FDA standards. We make sure that all food products, cosmetics, medical devices, and dietary supplements comply with FDA regulations.
https://www.exportusa.eu/fda-compliance-exportusa.php