10 replies to this topic

[jcieslowski]

Yesterday, one of our suppliers informed us that one of their suppliers informed them of potential metal contamination at less than detectable levels (<1.5 mm ferrous metal) at their facility, our supplier facility, or our own facility.

 

I prepared for a recall and gathered my info, waiting for the recall notification.  Today, the supplier tells me the original supplier is considering it a 'voluntary quality notification'.  

 

MY GM says, basically, 'well if it's not a recall, we're off the hook'.  This has me... uneasy.  Can someone point me to the specific legislation related to this type of situation so I can provide some guidance to my boss?

 

Thank you much,

 

John

 

[G M]

You set the minimum risk threshold for your raw materials and finished goods in your HACCP plan (probably).  Is 1.5mm ferrous below your stated acceptable value?  Presumably your inspectors and auditors accept your hazard analysis for the size you have selected if they haven't cited you for violations or non-compliance.

 

The FDA and UDSA do have some stated minimum, but it's much larger than industry standards. (6-7mm?)

 

Beyond that you just need to believe that your process is eliminating any reasonably predictable threat.  No one has organoleptically detected tiny metal particles, etc.

Edited by G M, 08 December 2022 - 10:32 PM.

[jfrey123]

It sounds to me like there wouldn't be a recall unless your upstream supplier issues one, or you perform some kind of internal investigation and find cause to issue one on yourself.  It's likely whatever breakdown your supplier has had, they've considered/reviewed it and deemed that there is not a risk of injury or illness in the product they supplied to you.

 

You've now got notice that your supplier has insufficient controls to prevent metal from coming in with supplied product, which should be considered in your supplier approval/monitoring.

[Tony-C]

Hi John,

 

So, my understanding is that your supplier’s supplier has a problem with metal contamination of a material that goes into a material supplied to you.

 

In addition to that, they have decided this contamination is not a food safety issue but a quality issue!

 

My reaction would be to put all of the relevant materials and products that you have control of on hold and request an urgent investigation and report.

 

Based on that I would then decide how to proceed with product in the market.

 

Kind regards,

 

Tony

[Scampi]

Here is the piece of legislation

7. When is a food considered adulterated under Section 402 of the FD&C Act? Section 402 of the FD&C Act?

 

includes many reasons a food may be adulterated including: • If the food bears or contains any poisonous or deleterious substance which may render it injurious to health; consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise unfit for food; or has been prepared, packed, or held under insanitary conditions whereby it may be rendered injurious to health; • If the food is a dietary supplement or contains a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling; is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury; or is a dietary supplement declared by the Secretary to pose an imminent hazard to public health or safety.

 

https://www.fda.gov/...levels-handbook

EXTRANEOUS MATERIALS

Any foreign matter in a product associated with objectionable conditions or practices in production, storage, or distribution. Includes: objectionable matter contributed by insects, rodents, and birds; decomposed material; and miscellaneous matter such as sand, soil, glass, rust, or other foreign substances.

[Scotty_SQF]

I personally would be pushing back hard and asking for a report of their findings and justification of their decision.  As I would want that to keep on file.  Read through it and if something seems off, ask questions until you feel comfortable with it.  You ultimately have the power to decide to un-approve a supplier.  Just because the supplier says it's fine does not mean your facility just drops it and goes along with the decision.  Do your due diligence to protect your product and your customers.

[jcieslowski]

Thanks all.  To respond to some and also give an update (but trying not to be too specific as I suspect litigation might end up being involved... ugh)...

 

Our supplier notified us of the problem and it was a fast moving situation.   I went ahead and put all of our product (raw material and finished) on hold, and contacted the few customers we shipped finished product to and they put it all on hold, awaiting a review / analysis from the original supplier and update from our supplier.

 

Basically, I've got thousands of cases of product (and dollars) on hold throughout the chain but mostly in my facility.  

 

Now the original supplier has come back and said they don't believe it to be something injurious as it's thin threadlike strands that are .38mm wide and of varying lengths with the longest being about 14mm.  They, our supplier, and us, all have metal detectors that were not triggered anywhere in the process.  They determined this to be a quality issue and think that it would be, at worse 'like a hair' to the consumer.

 

I'm pretty sure I don't agree with this substance.  I went round and round in various regulatory codes to try and make sense of 'adulterated', 'injurious', and  'deleterious' and I think I've come to the conclusion that even though it's very likely to not be injurious it is not material added that is needed or can't be controlled by cGMP so I think it still fits the definition as deleterious and thus adulterated and can't be sold (at least interstate?).

 

Our supplier, for their part, has issued a withdrawal and want us to return our on hand inventories of the material.  This doesn't pass the smell test to me (if you're not willing to stand by the product you've given to me, how can you expect me to stand by the product I'm giving to my customers made with your product?).

 

I'm fairly sure they're doing this because they don't want to pay for all of our already made and shipped cases. 

 

But my take on it is moot at this point because the product is all on hold so there's no risk, and our legal counsel is getting involved.   

 

Thanks for helping set my mind right everyone, I appreciate you and the IFQSN 

[MDaleDDF]

Product withdrawal and return.   Voluntary quality notification?  Sure sounds like a recall to me, lol.   A 'notification' is nothing more than that, and would require no product to be returned.  They're asking for product back, but not calling it a recall?  They're basically saying it walks like a duck, it quacks like a duck, but trust me, it's a cow.....

Anybody else think they're going to end up with an issue here?  I agree this doesn't pass the smell test, at all.   If this were a smell test, it would smell like the south end of a north bound cow....

However, no metal kickouts.   You either trust your MD or you don't.   I trust ours 110%, and I'm absolutely positive if there's the smallest piece of metal in one of my bags, the machine will find it.

Edited by MDaleDDF, 09 December 2022 - 06:01 PM.

[jcieslowski]

" You either trust your MD or you don't." 

I trust our metal detectors fully but not if it's a 0.3 mm by, say 0.8mm.  That's below our detectable limit.

[MDaleDDF]

Well why do they set limits there?   If it's outside the limit set by the governing body, it's ok on any other day.   Why should this day be any different....

I'm not saying that would be my position, I'm just a sayin'......

[PieGuy191]

 Check out FDA Compliance Policy Guide 555.425.  Foreign material that is 7-25mm in size is considered a health risk.  Doesn't matter if it is .38 in diameter if it is 14mm long.    

Attached Files

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