USFDA foreign food manufacturing facility inspection

Good Morning Everyone,

 

Hope you all are well and looking forward to much deserved X'Mas break.

 

We are food manufacturing company in Australia and are registered with USFDA as food manufacturing facility as we sell our products in US through one of the retailers in AUS. We sell 2 products under supplement and 2 under food category.

 

Recently I received an e-mail from FDA proposing to audit us under USFDA foreign food inspection program.

 

Could I please get help in what to expect in this audit.

 

There is lot of information on USFDA website but just wanted to hear from anyone who has experienced it first hand.

 

Thanks in advance.

 

 

Good Morning Everyone,

 

Hope you all are well and looking forward to much deserved X'Mas break.

 

We are food manufacturing company in Australia and are registered with USFDA as food manufacturing facility as we sell our products in US through one of the retailers in AUS. We sell 2 products under supplement and 2 under food category.

 

Recently I received an e-mail from FDA proposing to audit us under USFDA foreign food inspection program.

 

Could I please get help in what to expect in this audit.

 

There is lot of information on USFDA website but just wanted to hear from anyone who has experienced it first hand.

 

Thanks in advance.

 

Hi QMA,

 

Interesting Post.

 

I had always thought such (official) events were typically a by-product of a Gov-to-Gov MOU type arrangement (exists for USA/Australia?).

 

Offhand I cannot recall any such (US)-related event being previously discussed here. 

Good Morning Everyone,

 

Hope you all are well and looking forward to much deserved X'Mas break.

 

We are food manufacturing company in Australia and are registered with USFDA as food manufacturing facility as we sell our products in US through one of the retailers in AUS. We sell 2 products under supplement and 2 under food category.

 

Recently I received an e-mail from FDA proposing to audit us under USFDA foreign food inspection program.

 

Could I please get help in what to expect in this audit.

 

There is lot of information on USFDA website but just wanted to hear from anyone who has experienced it first hand.

 

Thanks in advance.

 

Question - are your products that you are shipping into the US "FSVP" or not?

 

Question - since it was a "proposal" email - does this mean they are giving you an option of saying no?

 

 

All Foreign Suppliers to US importers are required to comply with the Foreign Supplier Verification Program" that is administered by the USFDA -- this could be that type of audit if your company has not qualified under the FSVP.

 

This FSVP thing is becoming a monster.

 

Hi QMA,

 

Interesting Post.

 

I had always thought such (official) events were typically a by-product of a Gov-to-Gov MOU type arrangement (exists for USA/Australia?).

 

Offhand I cannot recall any such (US)-related event being previously discussed here. 

 

Thanks Charles.

Yes there is MOU but it appears because 2 of products we are selling are supplements hence this inspection.

Extract from Aus border force website

 

Current food safety recognition agreements/arrangements

Australia -US Food Safety Recognition Arrangement

The department signed an agreement with the US Food and Drug Administration (US FDA) in April 2017, recognising that Australia’s food safety system and the US food safety system are comparable / equivalent to each other.

Foods covered by this agreement include:        

• Canned foods
• Dairy products (excluding U.S. Grade A milk and milk products)
• Fresh fruit and vegetables
• Most Seafood
• Fruit juices
• Confectionery
• Baked goods; and
• Game meat

Food not covered by this agreement include meat (except game meat), poultry, processed egg products, raw bivalve molluscan shellfish, raw milk cheese and dietary supplements and natural health products.

Question - are your products that you are shipping into the US "FSVP" or not?

 

Question - since it was a "proposal" email - does this mean they are giving you an option of saying no?

 

 

All Foreign Suppliers to US importers are required to comply with the Foreign Supplier Verification Program" that is administered by the USFDA -- this could be that type of audit if your company has not qualified under the FSVP.

 

This FSVP thing is becoming a monster.

Thanks

Question - are your products that you are shipping into the US "FSVP" or not?

 

It appears so .Where would I get this information from whether product is FSVP or not.Its Spirulina and beetroot powder. One is categorized as supplement and other food.

 

Question - since it was a "proposal" email - does this mean they are giving you an option of saying no?

They are giving option but considering we sell volumes ,management wants to go with  proposal. It is 3 full day audit hence was thinking if anyone can share their experience I can use in preparation.

Hi QMA,

 

My experience shipping to USA is prior to when the FSVP juggernaut started.

 

I would have thought that yr importer would have been (visibly) pestering you for data if you are involved with FSVP but SQFC can probably answer yr immediate queries better than I.

Thanks

Question - are your products that you are shipping into the US "FSVP" or not?

 

It appears so .Where would I get this information from whether product is FSVP or not.Its Spirulina and beetroot powder. One is categorized as supplement and other food.

 

Question - since it was a "proposal" email - does this mean they are giving you an option of saying no?

They are giving option but considering we sell volumes ,management wants to go with  proposal. It is 3 full day audit hence was thinking if anyone can share their experience I can use in preparation.

As the exporter (your company) it is your responsibility to check to see if your products need FSVP -- there is a bit of documentation involved - should take a look at the FSVP on the FDA website to verify if it applies to your company/products that are exported to the US.

 

As Charles mentioned it would be the importer in the US that should be pestering your company for FSVP.

 

We are finding however that most are not pestering their Foreign exporters - this is a worry indeed as it can sure mess up the supply chain if the exporters stuff is stopped from entry.

 

Currently we are vetting suppliers for one of our clients and while the client is not an importer they are getting product from brokers that are buying from foreign companies and we are asking each one for FSVP verification and finding NO COMPLIANCE.

 

My suggestion is that your management might think having a 3-day super audit by the FDA as a good thing, if your company is required to comply with FSVP and cannot show proof of this having that audit would be like having your pants down and awaiting a bad spanking.

 

Make sure you are clear of being required to participate in the FSVP or if you must and then get it in place as fast as possible and then invite them over for their super audit, because a 3 day audit is exactly that - a super audit.

Hi QMA,

 

Just to add that there are numerous previous threads here on the expectations associated with fulfilling FSVP. (I daresay you are familiar with such already).

As the exporter (your company) it is your responsibility to check to see if your products need FSVP -- there is a bit of documentation involved - should take a look at the FSVP on the FDA website to verify if it applies to your company/products that are exported to the US.

 

As Charles mentioned it would be the importer in the US that should be pestering your company for FSVP.

 

We are finding however that most are not pestering their Foreign exporters - this is a worry indeed as it can sure mess up the supply chain if the exporters stuff is stopped from entry.

 

Currently we are vetting suppliers for one of our clients and while the client is not an importer they are getting product from brokers that are buying from foreign companies and we are asking each one for FSVP verification and finding NO COMPLIANCE.

 

My suggestion is that your management might think having a 3-day super audit by the FDA as a good thing, if your company is required to comply with FSVP and cannot show proof of this having that audit would be like having your pants down and awaiting a bad spanking.

 

Make sure you are clear of being required to participate in the FSVP or if you must and then get it in place as fast as possible and then invite them over for their super audit, because a 3 day audit is exactly that - a super audit.

We already have HACCP,ISO 9001:2015,USDA-NOP certifications in place and are Australian trusted trader so we have systems in place but you are right it would be disastrous to enter audit room underprepared.

I assume they would like to check our cleaning program, testing procedures, approved supplier program, micro testing and nutritional claims , printed packaging version control etc.

We already have HACCP,ISO 9001:2015,USDA-NOP certifications in place and are Australian trusted trader so we have systems in place but you are right it would be disastrous to enter audit room underprepared.

I assume they would like to check our cleaning program, testing procedures, approved supplier program, micro testing and nutritional claims , printed packaging version control etc.

 

Hi QMA,

 

IIRC the specific, detailed expectations for FSVP are officially "spelled out" and variously referenced/discussed in the threads I mentioned earlier.

Good morning, Here are my employee trainings that describe what the FDA is looking for, for FSMA it is all preventive and if you have a 3rd party audit most of it is done for SQF and BRC. if you need more specific items let me know at xxxxxxx we just went through our audit within the last year.

Thanks Charles.

Yes there is MOU but it appears because 2 of products we are selling are supplements hence this inspection.

Extract from Aus border force website

This is important, you have modified requirements under FSVP and are exempt from a bunch of FSMA components for your dietary supplements.

 

For the FSVP details, search for the dietary supplmements modified requirements in this guidance: https://www.fda.gov/...110327/download

Several years ago I helped a company in Ecuador prepare for a FDA seafood HACCP audit. Seafood HAVCP rules are a little different from FSMA, but I expect that the process would be similar.
If you decline the audit, then your facility registration can be suspended and your products will not be allowed into the US. So please give them the ok.
Make sure you understand the appropriate regulations and follow them. Since Australia has the MOU for food, the rules should be very similar to your own. I have not dealt with supplements so can’t speak to those rules.
My experience with FDA is that they will want to see your written programs, observe your process, and observe a pre-op inspection. They may or may not take samples of products but will likely ask for samples of labels. Expect to have them for 2-3 days.
Good luck!

I forgot to say that although US and Australian rules are similar, they are not identical. Make sure to read the FDA regulations carefully, and where US rules are different, make sure you can show that you are following the US requirement.