We prepare the HARPC manual for you to be able to export food products to America
The FDA consultancy service offered by ExportUSA also extends to FSMA and FSVP compliance
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.
Preparation of the Food Safety Plan is part of the FSMA regulation
ExportUSA offers the ENTIRE range of services to comply with FSMA, the new FDA directives for exporting food into the United States of America
The FSMA compliance service is divided into two parts:
- the first part analyses the current situation of the company [the so-called "Gap Analysis"],
- while the second part provides for actual compliance with the provisions of the FSMA for importing to the United States
Our compliance services aim to allow producers to continue exporting food products to the United States of America without interruption.
Preparation of your company's HARPC manual
We create the Food Safety Plan required by the FDA
Our food technologists will work closely with your quality department or with your internal quality officer to create the HARPC manual and the plan of periodic internal controls that you need to carry out and record.
We provide the external PCQI service, in outsourcing
If you do not have an internal expert to implement the food safety plan [the so-called "PCQI" - Preventive Control Qualified Individual] we can carry out this service in outsourcing [which is explicitly allowed by the FSMA regulations]
We keep in contact with your American Importers
For the first time, American importers become part of the control chain of food products for sale in America.
It is a new role for them and constant contact will be necessary, at least at the beginning, to avoid confusion and misunderstandings.
ExportUSA, with offices in Europe and an office in New York, is in a unique position to maintain contact with your American importers.
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, compliance with the FSMA rules 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.