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FDA comes with a new foreign suppliers strategy

06/03/2019 | Bart Bosch | General

The FDA released a statement on February 25, 2019 on a new strategy to advance their mission on food safety and modernize oversight of imported food.

One of the pillars, and the one having the most focus in the news release, is preventing food safety problems in the supply chain prior to entry into the US. Which means approving sites that make products going to the US.

One of the tools the FDA is using, is on-site inspections of foreign facilities, which is taking more resources than expected. Therefore they are going to focus more on the "Foreign Supplier Verification Program (FSVP)". 

The second tool is the "Accredited Third-Party Certification Program", where the FDA is using the data to risk assess the foreign supplier to establish their own inspection program. This ATPCP can also be used by a new program that was introduced by the FDA in October 2018: the "Voluntary Qualified Importer Program (VQIP)" where the importer has to guarantee that the suppliers are having an accredited third-party certificate. Important to know is that the ATPCP only accept certificates based on unannounced audits!

A third route the FDA is taking, is recognizing countries's food safety systems and oversight activities providing comparable levels of public health protection to the ones in the US. 

Quontinuim is an independent audit organisation that has no link with any certificate a company might have. It's not that we don't know the standards and how to implement them, only we keep out of the commercial certification system. In that respect, we already carry out supplier and contract manufacturing audits for a US company and we use their standard to make sure suppliers are assessed to the correct requirements (regulatory and corporate). 

Contact us to discuss how we can help you: info@quontinuim.com

The full press release can be found here:

Statement from FDA