An FSVP template or example doesn't exist.
This is because every FSVP plan will be unique to your specific product and its manufacturing environment, as well as your country of origin. An FSVP plan has no set format, it has to be approved by a Preventative Controls Qualified Individual (PCQI) to be valid. This means that you have to provide the correct documentation for a PCQI to assess before it will be accepted by the FDA. Essentially the FSVP plan exists to show that you are fully complaint with FDA requirements, and is backed up by the approval of a food safety expert.
Whilst there are some similarities between FSVP plans, there is no definitive format. Each FSVP plan must be designed for your situation otherwise it will fall foul of FDA sanctions at some point.
What documents do you need for an FSVP assessment?
Most FSVP plans must show substantial evidence that the products manufacturer or supplier has the appropriate documentation in place to fully justify that the product has been produced to the same quality of that which is expected in the United States. Typically you will require the following documents :
Food Safety Certification - Specifically GFSI certification, if you have any of the highest standard certification bodies such as BRC, SQF and FSSC 22000 then you are in a good starting position. In order to get these certifications in the first place you must have some form of food safety procedures in place.
Product Specification - In order to carry out an FSVP assessment you will need to have fully detailed specifications for all products being assessed, they must give details on all nutritional values, all additives and any allergens (potential or present). This allows the PCQI assessor to ensure that the products being imported to the USA are entirely safe and legal for the population to consume.
Food Safety Plan - A full food safety plan or HACCP plan needs to be in place and verified as 'in use' and effective. The plan will, ideally, be in the Preventive Controls format, although a standard HACCP plan is allowable. The food safety plan needs to then be assessed by a PCQI assessor to ensure that the products being imported to the USA are entirely safe and legally compliance with FDA Final Rule on FSVP.
Allergen Compliance - Allergens in the USA may be different from those listed in the Country of origin. Any US listed allergens need to be checked by a PCQI assessor to ensure that the products being imported to the USA are entirely safe and legally compliance with FDA Final Rule on FSVP.
Additive Compliance - Additives for food products in the USA need to be checked as there are many that are banned and their presence in a product being sold in the USA would be illegal. Any US additives need to be checked by a PCQI assessor to ensure that the products being imported are in compliance with FDA rules on additives.
Laboratory Analysis and Contact Surfaces - This is intended to ensure that your products nutritional, allergens and additives values are backed up by scientific validation and that calculations and the manufacturing processes are well documented. It can also be use to verify the actual ingredients and ensure that allergens are not present.
US FDA Compliant Labels - If you are going to sell your product to the US general public, you must have the correct labelling that is in line with FDA regulations. This should be included with your plan, with the correct nutritional, allergen and additive information included. However labelling is not a 100% requirement to complete an FSVP plan, although it is legally required by the FDA, you can carry out the FSVP assessment before the labelling.
Again, whilst there is no set format for the FSVP Plan and Assessment, it is safe to assume you will require these documents. However you may require less or more documentation on your product depending on its type and calculated risk factor.
We Can Help
Sound like more trouble than its worth?
It is. especially if you have little to no experience in food safety. Unfortunately we cant provide you with a template as there is no such thing, however, we can build your FSVP for you.
Our PCQI network specialises in helping you get complaint for the US Market. We can do the process entirely electronically through our unique software system which makes the whole process quick and efficient.
We specialise in helping foreign exporters reach the US market legally, safely, quickly and at low cost. If you want to build your FSVP plan and get ready for the US Market.
Contact us Today
We will help you get compliant with FDA from start to finish. We can cater specifically to your business regardless of if you already have some compliance measures in place or none at all.
We offer every service you need to be compliant and legal for the US Market, at a very reasonable cost, including :
- FDA Registration
- FSVP Assessment / Plans
- US Label Reviews & Designs
- FSVP Import Agent Services
- Tariff & HTS Code Advice
- Prior Notice and Importer of Record Services
We will always advise our clients on the best possible route to get fully compliant as fast as possible and at the lowest possible cost. We also offer additional food safety services such as HACCP Plan reviews, Amazon FSVP and Trade show FSVP plans. Please check out our full service page if you would like to learn more.