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FSMA certification: The new FDA import regulations go by the name of FSMA [Food Safety Modernization Act]. All food producing and exporting companies are required to set standards for selling food products in America

At the heart of the new FDA regulations and FSMA procedures is the adoption of the HARPC plan [Hazard Analysis and Risk Based Preventive Controls] - a series of protocols and procedures for the control and prevention of risks inherent in the treatment and production of food products. It is similar to HACCP but takes a different approach to the problem of food safety

Let us introduce the ExportUSA FDA team: its members speak your language, answer from its office in your country and, above all, listen to you and know how to provide the best advise. They are there when you are there. Always.

Claudio works in the Rimini office.

He deals with FDA, SID/FCE registration, and FSMA and FSVP compliance.

Claudio is the face and voice of ExportUSA for all customers who need advice on everything that is FDA-related. A friendly voice and temperament, always available to listen and a familiar voice for our long-time customers.

Cinzia, historical presence at ExportUSA,

works in the Rimini office, and assists customers who need to apply for an USDA - US Department of Agriculture import permit [and nothing escapes her...] 

Gaia works in the New York office, 

and deals with FDA certifications and label review. Gaia works closely with Claudio and together they are the winning duo for a successful FDA inspection on food specialties! [...but also inspections by the US Customs] 

Astra works in the New York office. 

She supports Claudio and Gaia on matters concerning compliance with FDA regulations, and manages all the elements of such regulations applied to cosmetic products. The new generations move forward.

FSMA - The new FDA regulation for companies producing food products intended for export to the United States of America does NOT create new obligations relating to export: the export procedures and documentation for importing into the United States remain the same as those already in force

The FSMA regulation and the adoption of the HARPC protocol are instead important in the inspection of production plants by the FDA

Manufacturers that do not have the Food Safety Plan [HARPC manual] will in fact be prohibited from importing food specialties into the United States

Contact us for more information on how to bring your company into compliance with FSMA

The new FSMA regulation issued by the FDA essentially requires manufacturing companies intending to export food into the United States to adopt the Food Safety Plan [HARPC manual], a protocol of systems and procedures typical of the United States, similar in part to the HACCP system

During the inspection, the FDA checks the adequacy of the HARPC plan adopted for that type of food product and for that type of production process and the correct adoption of the protocols, processes and procedures envisaged by the HARPC plan adopted.

Upon inspection, companies that are found to be non-compliant with FSMA will no longer be able to export to America until they are compliant. In the most serious cases (for example if health problems arise as a result of consumption of the products offered for sale in America) criminal sanctions are applied.

The control system is made much more efficient and reactive by the fact that now American importers are also obliged to check that the food products they import into America come from producers / exporters in compliance with FSMA regulations.

FSMA certification: who must comply with the FSMA regulations

All manufacturing companies that intend to export food to America are required to comply with the provisions of the Food Safety Modernization Act. However, the latest dates for compliance vary according to the size of the companies. 

FSMA general rule: compliance within September 26, 2016:

Companies exempt from the obligation to comply with the FSMA regulations

What it means, in practice, to comply with the new FSMA regulation

In reality it is less complicated than you might expect, especially for food companies which have always been attentive to product quality and in any case obliged to adopt a HACCP plan.

A HACCP plan can be just one step in many, but is however of great help because most of the procedures included in the HACCP plan can also be included in the HARPC plan / manual, and also because the methodologies are common and familiar.

A significant difference consists in the so-called Hazard Analysis [analysis of the risk inherent in a certain food production] and in the obligation to keep records [prompt recording of the controls that the HARPC plan defines as necessary]. In practice, for a company of standard structure, it only involves implementing documentary procedures, applying them and keeping them updated.

ExportUSA offers all the services necessary to comply with the new FSMA regulation: from technical analysis and consultancy services, to process and procedure implementation services.

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FDA Compliance

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.