If we add a serial number to labels do we have to resubmit our labels for approval to USDA and FDA?

Our company prints some of our labels in house. We are a RTE sandwich producer. There have been many instances of mislabeling and some customers have received wrong product due to this issue. I am new to the company and at my previous place our labels were serialized so that we could account for labels returned without physically counting labels on the roll that were left over.

 My previous employer however produced for further processing. 

My question is: If we serialize labels here and I am talking about just a small box on the corner of the label with a number, do we have to resubmit our labels for approval to USDA and FDA?

        The label checks they already have in place are obviously not effective, because they continue to have issues so I feel like accounting for the labels and having them checked in after a changeover would prevent this. 

Thank you in advance for your assistance! 

what is your current process?  You may not need to change the label

All of our products are brought in cooked. Buns, meats, cheeses. We assemble here and package. And our sandwiches are sold in stores or vending machines. Some products are USDA and some are FDA. Labels are pulled from our components to verify the finished labels is correct, and printed in house for the majority of product. Some items are sent by the company preprinted.  When a changeover occurs typically the labels left over are tossed into the trash. Sometimes this does not happen and they are left on a cart and I believe that's where the errors are occurring. 

   I wanted to do the numbering so that we could verify the extra labels are being returned and disposed of by one person instead of relying on a line leader to just say yeah i threw it away.

I'm not familiar with this part of your question:

do we have to resubmit our labels for approval to USDA and FDA?

I've never submitted labels to either regulatory body for approval, is this something particular to RTE?

Agree with TimG, never done that either. It's a manufacturer responsibility to ensure that label information is correct and comply with all related (local and country of sell) regulatory requirements.

I can't say if its just the requirement of our inspector or a child nutrition program that we do. It could also be the sites constant errors in labeling. i have only been here a few weeks and answers to questions aren't well received :) . But the process is now if there is a new label for a new product or a label change (allergen or use by) we have to complete a generic label approval for the change and then have it submitted. 

Ok, let's focus on this one because I think it answers your original question:

I can't say if its just the requirement of our inspector or a child nutrition program that we do.

Those are two real possibilities, your USDA inspector (it wouldn't be FDA, they probably come by once a year if you're unlucky) might have requested all label changes be vetted through them due to the labeling issues in your history. Also, being part of a grocer/dist that distributed to child nutrition locations (pre-k, K, etc) they have very strict requirements, so it's a real possibility that is one of them.

The thing with both of those is that no one here can tell you the answer to that, that's something you will have to reach out to your USDA inspector (they are on site a few days a week right?) or your product managers (or whoever handles your customers).

Ok thank you. I appreciate you taking the time :) 

No problem!

I will say that the answer is going to most likely be 'no' they won't need to review, if it's a simple addition of sequential numbering.

But it's best to get that in writing (or email) from whomever requested to be notified of the label changes in the first place.

a lead hand needs to supervise the change over AND record it, that means taking 5 random finished products and verifying that the label is the correct one for the product in the package, you may need to enforce this change in the beginning

having the labels serialized is not going to correct the issues on the floor---you need to ensure everyone understands the implications (worst case scenario) of not using correct labels on your product.  These should be terms of employment IMHO

This is a good example about culture in the workplace---you need to show your authority, and in my experience, re-enforce training with real world scenarios of the WORST CASE scenario. People don't forget that stuff

I haven’t worked much with USDA, but I believe that labels for USDA inspected products need to be approved by the agency. Also, there are specific labeling requirements for some government programs, such as the Child Nutrition program you mentioned. I suggest you contact the agency directly if you can’t get the answer from their website or from your on-site inspector.

The company I work for also makes RTE product - we've never submitted our labels for regulatory review.

Is your product in general retailers, or exclusively for child nutrition providers? I have a colleague who works for SNAP (food stamp) agency and she does review nutrition contents but not quite sure if "approves" them. 

I would agree with the points above. make sure to document changes, conduct a training, and document the checks; taking samples and verifying that all labels are the one currently approved for use. Needs to be signed off that the samples checked were in fact using the correct label. How are your workers verifying they are using the correct label in the first place during processing / production? 

regarding "serialization" : is there a reason why your company needs to keep the outdated labels? if the  "old" labels are being discarded / removed (and recorded that it's been done so). this would eliminate the potential mistakes that could occur even serializing a label.

-sorry in advance for any grammar, english is not my first language and i'm not well rested lol.-