Supplier Testing - Listeria mono positive

Hi All,

We recently tested two incoming lots of ingredient from a high risk supplier. Both lots were positive for Listeria monocytogenes. We contacted the supplier and were also instructed by the FDA to submit a reportable food registry report. Our lab sent the isolates to the FDA for further genetic testing. Our supplier has not been cooperative and did not previously have a sanitation schedule nor an environmental monitoring plan. This truly seems like it is an environmental issue at our suppliers facility. We immediately suspended all supply of ingredient from this supplier. Our supplier stated that the FDA inspected them and told them that they can sell the product that tested positive for L. mono because all of their results were negative. I searched on the FDA website for inspection dates for this supplier. The FDA website is up-to-date as of 4/14/18 and the audit of our supplier was supposed to have occurred 3/9/18. There is no record that the facility was inspected.

I thought that the FDA had to publish all facility inspection dates. I checked the website and all of our own facilities inspections are listed on there. Could this supplier be lying to us about having an FDA inspection? How could it even be lawful to sell an ingredient that tested positive for L. mono?!

I am extremely concerned that either the supplier is not being truthful or that the FDA is not following through from our reportable food registry report. How can we ensure that action is taken?

Thank you for your help!

I would think that if your inspections are all listed and none of theirs are that you need to find a new supplier for this material and wash your hands completely of them. This is why we all have to follow new GFSI, because some companies are still suspect.

Alternatively before you pull the trigger, and since you have done all of your due diligence to ensure that this product did not reach the consumer, I would speak to your FDA inspector about this directly. I would hope under these circumstances that the FDA works with you

As you have stated that your supplier is not being cooperative AND you knew they didn't even have a sanitation schedule, my guess is they NEVER tested the material...........if they aren't spending money on the obvious things, they are certainly not spending it on the IMPORTANT things.

Consider this a lesson learned for your company about sourcing material from reputable companies. But I think you have an ethical responsibility to notify FDA of what your supplier has communicated to you as you won't be their only customer

From the Food Code Laws 21US Code 342 Audulterated Foods

A food shall be deemed to be adulterated—

Wow, a lot to unpack here.

1. You seem to be responding appropriately, good job!

2. Even if you can't tell us what ingredient it was, telling us the type of ingredient (vegetable, spice, wet, dry, etc.)

3. Excellent work checking the FDA inspections database, but unfortunately it's not a good tool. None of the inspections conducted by contracted state workers make it into the database, only those conducted by federal FDA employees. Your supplier may very well have been inspected, but it could have been a state contracted inspection. The database is notoriously incomplete (e.g. you can look up inspections in warning letters conducted by FDA, but not find them in the database).

4. Even if they were inspected by FDA, frankly FDA inspections are mosstly useless and most facilities aren't being inspected against part 117 (FSMA Preventive controls) anyway. In general, all State/FDA inspections do is inspect facility construction and pest control. Remember that FDA inspected Peanut Corp of america.

5. There's probably more to their story regarding what FDA advised them to do regarding the L. mono positive reported by you, their test results, and the scope of the issue. However, given that you noted they did not previously have a sanitation schedule, this supplier clearly has no one qualified on staff to make that decision or understand what exactly FDA was recommending. Seriously, suppliers that don't even have a program to clean their s*** clearly do not have the necessary knowledge or willingness to understand food safety principals to make decisions based on "test results". They have no idea what they mean statistically and clearly consider your test invalid just because their particular 25 gram sample came back negative.

Cut your ties and inform FDA, you've done that. Unfortunately because FDA sucks at enforcement, the supplier will likely keep on selling their contaminated products until an outbreak occurs, then FDA will bring the hammer once people get sick, they're a reactive organization. You've contributed to food safety by punishing them with the loss of your business.

"Our supplier stated that the FDA inspected them and told them that they can sell the product that tested positive for L. mono because all of their results were negative."

There is no way the FDA is going to inform a company this is OK.

Personal OPIN - they are lying.

You can back that up by asking for a copy of the FDA inspection report and the statement from the FDA in writing that it is ok to sell.

Considerng that you will not receive this, then you run away from them, report them and get a truthful supplier.

Playing devil's advocate here:  Is the ingredient considered ready-to-eat?   If the ingredient is intended to be used in a process that will receive a kill step, then it is more of a contractual issue between you and the supplier than it is a regulatory issue.  The definition of ready-to-eat is a bit fluid these days, but the FDA requirements for environmental testing only apply to ready-to-eat products. That being said, if they do not have a good sanitation program in place, then you will not want to do business with them anyway.

Hi All,

 

We recently tested two incoming lots of ingredient from a high risk supplier. Both lots were positive for Listeria monocytogenes. We contacted the supplier and were also instructed by the FDA to submit a reportable food registry report. Our lab sent the isolates to the FDA for further genetic testing. Our supplier has not been cooperative and did not previously have a sanitation schedule nor an environmental monitoring plan. This truly seems like it is an environmental issue at our suppliers facility. We immediately suspended all supply of ingredient from this supplier. Our supplier stated that the FDA inspected them and told them that they can sell the product that tested positive for L. mono because all of their results were negative. I searched on the FDA website for inspection dates for this supplier. The FDA website is up-to-date as of 4/14/18 and the audit of our supplier was supposed to have occurred 3/9/18. There is no record that the facility was inspected.

 

I thought that the FDA had to publish all facility inspection dates. I checked the website and all of our own facilities inspections are listed on there. Could this supplier be lying to us about having an FDA inspection? How could it even be lawful to sell an ingredient that tested positive for L. mono?!

 

I am extremely concerned that either the supplier is not being truthful or that the FDA is not following through from our reportable food registry report. How can we ensure that action is taken?

 

Thank you for your help!

Hi kdiamond,

A rather fascinating thread.

The queries in Post 5 may be relevant.

If true the red above seems to imply that 2, presumably accredited,  labs totally disagree on the result of testing a, presumably, well-defined sample(s). (I presume "isolate" refers to a purified species-level sample).

I'm rather surprised that FDA would not have given some feedback regarding their discrepancy with first lab. if that were the case.

As per other threads, it seems the only way to reliably acquire the full history of the problem is to query the FDA.