Step 1. Letter of Engagement
Once considered our offer of services and opted to enlist BRAVO as your FSVP Agent, your firm will receive a signed Letter of Engagement with a Non-Disclosure Agreement enclosed, by means of which BRAVO assumes the responsibility of developing and carrying out your FSVP compliance plan. Since on, BRAVO, in the vest of your US resident FSVP Agent, is officially qualified to interact on your behalf with the Food and Drug Administration officials for any purposes and concerns relating to your compliance with the FSVP regulation and plan (see points 6 and 7 below) and its related record-collection (see point 8 below). Specifically, BRAVO as your FSVP Agent will act as your official correspondent/receiver for all concerned communications, inquiries, notices, responses, and similar, submitted to or received from the FDA in reference to the FSMA regulation.
Step 2. BRAVO Portal Customized Setup and Food-Safety Data and Documents Collection
BRAVO will register a secure client account at your name on its Portal by setting a dedicated client username and password. Once checked your firm’s information with the FDA categories defining your food products to be imported, BRAVO will send you a customized e-mail form on your client account and/or as an e-mail through the Portal. At that point, you will be able to fill out the form by inserting all the required data and documents in the respective fields. As soon as the Portal receives the form from your firm, a notice of service will be automatically generated, alerting the BRAVO’s Qualified Individual, who will thoroughly review your documentation as per completeness, accuracy, and compliance.
Step 3. FSVP Supplier’s Compliance Check.
Based on its initial evaluation, the PCQI will review the set of information and documents provided by the foreign supplier by means of the BRAVO Supplier’s Compliance CHECK FORM, and cross-check them with the US Law requirements appliable to the specific categories of your food products to be imported and all the processes put in place at its facility. BRAVO will determine the FSVP regulatory compliance status of the foreign supplier under the relevant FSMA rules when importing its products in the US.
Step 4. The compliance status of your labeling under the appliable US Labeling regulations
BRAVO US Labeling compliance service offers three options of labeling review processes, and your FSVP Agent will orient you in selecting the one most consistent with your firm’s actual needs of a compliance status review under the US labeling regulation:
- The US Label – Nutrition Fact Panel (NFP) Compliance Review is aimed to ensure that the information on nutritional facts, allergens, and additives used in the food products is reported and described on the labels in a form satisfying the relevant US requirements. (Please note that this review option does not cover the label-design compliance status, and this review process does NOT ensure that your final labels will be accepted by the US regulatory agencies with the current design as such).
- The US Label – Claims Review, which is carried out by our Qualified Individual/American Lawyer, is aimed to ensure that any nutritional claims on your labels that specify certain standard definitions of methodologies used, or ingredients contained, in your food products, such as Organic, Vegan, Biologic, and others, satisfy the appliable US certification requirements. (Please note that this review option does NOT cover the label-design compliance status).
- The US Label – Full Legal Compliance Review ensures that all aspects of your label have been exhaustively reviewed: nutritional facts, allergens, and additives used in your food products, as well as any nutritional claims qualifying your food products. This review option DOES also cover the assessment of the label-design compliance status.
Step 5. FSVP Plan Management
Once completed the first PCQI’s check on the information and documentation listed above, BRAVO as the FSVP Agent in charge will begin to develop and keep updated the FSVP Plan specifically customized for your firm, as required under Foreign Supplier Verification Program regulation, 21 CFR part 1, subpart L. The FSVP Plan is the most accurate instrument to assure your firm’s full compliance with the relevant FSVP rules of the FSMA regulation.
Step 6. FSVP Evaluation and Approval.
BRAVO will perform its independent Hazard Analysis on the finished products, as required by the relevant FSVP regulations, and execute the approval of the foreign supplier after reviewing the Food Safety Plans or HACCP Plans, its processes and procedures, along with any other food-safety documents linked to its facility and products provided by the foreign supplier. BRAVO will thus determine whether the latter has correctly identified and monitored any possible hazards by checking the supplier’s processes, procedures, and food products in light of the Foreign Supplier Verification Program regulation, 21 CFR part 1, subpart L. Moreover, BRAVO will generate an in-progress evaluation template on the compliance status of the foreign supplier with respect to its company performance and the types of corrective actions put in place when needed. By means of this instrument, BRAVO will monitor and assess any Notices of Import Alerts, Recalls, Warning Letters, and Import Refusals incoming from the FDA as well as the specific regulatory issues to readdress in view of a full FSVP compliance of your firm.
Step 7. The Verification Plan.
As required under FSMA regulation, BRAVO will carry out a set of check procedures apt to verify that the preventive controls put in place by the foreign supplier are consistently implemented and effective in minimizing hazards. Such verification activities include preventive control processes scientifically proved to ensure that the procedures adopted can identify such hazards and calibrate (or check the accuracy of) the monitoring activities and verification instruments, e.g. thermometers. Verification activities also include reviewing records to ensure that monitoring and corrective actions (when necessary) are being conducted. Verification activities must be documented, and BRAVO is required to determine the applicable frequency.
Step 8. Record-keeping and procedures for importing food exclusively from approved Foreign Suppliers.
BRAVO will monitor, consider, and evaluate any new notices that the supplier will receive from the FDA, such as Notices of Recall, Import Alerts, Warning Letters, Import Refusals, and any other kinds of issues inherent to General Food Safety laws and FSMA rules. BRAVO will repeatedly review any new Third Party Audits, COAs, Test Results, Corrective Actions, and Reanalysis of the Food Safety Plan, anytime any changes there may occur. In addition, BRAVO will book-keep all the FSVP records related to the evaluation and approval of the supplier and its products at least for two years from the date of entry.
Step 9. FSVP re-evaluation and re-approval of the foreign supplier
BRAVO, in the vest of your FSVP Agent, is required to re-evaluate and re-approve the foreign supplier:
- at least every 3 years, or
- at any time BRAVO receives notices of potential food-safety hazards, or whenever there is any changes in products, product specifications, processes, and/or formulation, or whenever any doubts may arise about the accuracy of the food-safety controls carried out or the authenticity of documents provided by the foreign supplier.
- At any time the foreign supplier and its products are subjected to Recalls, Import Alerts, Warning Letters, Import Refusals.