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Not necessarily.

However, if the aforesaid US subsidiary company/division does not dispose of personnel professionally familiar with the FSVP regulations and qualified for the role, it does need to retain a qualidied FSVP Agent

A qualified  FSVP Agent must be a US-resident professional specifically competent in the FSVP regulation, formally retained by the foreign exporter/FSVP importer to check and ensure that all the food products imported into America by the firm comply with the relevant US laws and can pass the FDA food safety controls.

Yes, it is.

Pursuant to the FSMA relevant dispositions, upon its designation, the FSVP Agent must designate an FSVP Qualified Individual for Prevention Controls (PCQI) as its assistant in drafting, monitoring, and keeping updated the importer’s FSVP Manual.

The standard requirements to pass the foreign supplier verification programs (FSVP) are as follows:  

• Providing risk analyses for all products to be imported into the US;
• Evaluating and approving foreign suppliers in consideration of their production processes, singles ingredients used in such processes, and categories of products to be imported into the US;  
• Pinning down and implementing the verification activities specifically relevant to each and any foreign suppliers;
• Implementing correction procedures (when necessary);
• Representing the importer in the identification procedure when the shipments enter the US and acting as the official record keeper of the importer before the FDA for all the documentation and register keeping relevant to the FSVP regulations for a minimum period of two years;
• Subsequent foreign supplier’s  evaluations and approvals (with at least triennial frequency).

The FSVP Agent must ensure that all the food products to be imported into the US satisfy the same food safety regulatory requirements which apply to the American producer and distributors. Also, the FSVP Agent needs to specifically verify that the products comply with the US regulations aimed to sanction sophistication and/or improper labeling with respect to allergens.

The producer must draft a HARPC (Food Safety Plan) containing the following documents:

• A Risk Analysis aimed to pin down the possible hazards requiring preventive control.
• A certification attesting the preventive food safety controls performed at the production facility.

The Food Safety Plan includes preventive controls on the following areas of interest:

Production processes; hygiene and allergens controls; foreign supplier verification plan, along with a product recall plan from the American market; implementation of the aforesaid preventive controls and corrective/verification procedures.

Two options are available to the firm: Either correctly relabeling the products to keep marketing them within the US, or shipping them off the US, or destroying them at its own expense. Labeling incompliance constitutes one of the most common causes of block of sales which the FDA imposes, as well as the consequent product recall by the firm that undergoes the sanction.

A producer who is not compliant with the regulation PCHF of the FSMA and undergoes a FDA inspection, may incur the block of the product when the merchandise is still in the phase of importation into and/or recall from the American market. A producer, to be sure to obtain customs clearance and marketing feasibility in the States for its human food products, needs to demonstrate that its firm does meet the requirements and dispositions set on the FSMA.

A producer who is not compliant with the regulation FSVP of the FSMA and undergoes a FDA inspection, may incur the block of the product when the merchandise is still in the phase of importation into the US, and/or in the phase of recall from the American market. A producer, to be sure to obtain custom clearance and marketing feasibility in the States for its human food products, needs to demonstrate that its firms meets can meet the requirements and dispositions set on the FSMA.