Storage, Distribution, 3PL Facilities requirements for labels

Hi everyone,

I am wondering those that work strictly in distribution and storage, how much you may be involved with product label compliance?

I understand for traceability everything needs to be tracked.  But in terms of label compliance for products you did not manufacture, are you responsible for label accuracy?

I am asking because our state agency is telling us that we are responsible for things that we have no involvement in the manufacturing process.  We are simply storing and distributing.  Is anyone else in a similar situation?

Does your company own the product, or are you a 3PL?  If it's product your company purchases and owns I do not know what those requirements would be.

We are a 3PL and do not own any of the products in our facilities. We have a statement in one of our policies that we are not responsible for labelling as the customer retains ownership of the product while it's in our facility, and we address this in our Food Fraud Mitigation Plan. We have no responsibility for primary packaging labels.  

We do repack/relabel outer packaging for one customer, and we keep records of the labels and approvals for those projects only.  They are 3x5 label with the sku, product name, lot, best by dates, and the customer name that gets put in a plain brown cardboard box, but the customer retains responsibility for all the information on the actual label, we are just responsible for ensuring that the physical label printed matches the approved label they sent us. 

Edit...  my reading comprehension is lacking as I see the 3PL now.  :wacko:

Thank you for responding.  I understand that when you are repacking or relabeling than that is a step in the manufacture process so that makes sense why you would keep record of those labels and approvals.

We also do not have ownership of the products.  But we have been penalized for some of these labels having mistakes.  It does not make sense to me. So I am just trying to build a case to support our role in it.

An auditor suggested it during our initial audit after we showed him email records of the labels. Mostly it's a CYA for us.

Our process now is:

The customer sends us a label sample via email.

We print on our label printer and scan it so they can check and approve via email that the print job is accurate.

We print the email approval and compare the printed label and their original email to make sure it matches letter to letter and number to number.

We stick the printed label to the email copy (or staple if not enough room), then whoever does the verification signs and dates the page and makes sure part of their signature is also on the label.

We keep these copies for 3 years (shelf life ranges from 3 months to 2 years so we keep them together by calendar year so we don't have to stress about accidently shredding something we shouldn't).  We also haven't done a whole lot of relabeling until this year, we've had more projects so far than we have the last 2 years combined.

Some products contain allergens, but our customer does not mark their finished products outer case packaging as containing allergens (just says milk chocolate or dark chocolate w/almonds).  Per the auditor suggestion, we also verify via email that they do not want the allergens listed with a "contains" section on the outer case.  We build variety packs in a plain brown box with the finished product inside and all that information is on the primary packaging labels.     

It's all to protect us from getting an NC because we can show proof we are following customer requirements.

Thanks for your process.  We do receive label approvals too for in an instance we are doing labeling.

The labeling process is so complex, there is a lot of moving parts.  But I see you're not actually making the labels just printing them.  We do make some labels and have a process for that and the relabeling.

However, we have gotten cited for mistakes on labeled product that we are simply storing and shipping out.   It does not make sense, when we are not the manufacturer and not performing any processing steps.  But I haven't been able to find any FDA regulations specific to this issue.

If you are creating the labels, at minimum you should be sending them to the customer for approval before you use them.

If it's the customer placing the label and it's wrong...  I have it is a couple SOP's that customers are responsible for all labels as they retain ownership of the product while it's in our facility.  I do have that if we find a non-conformance we will put the product on hold for customer review, but usually it's either something leaked and the label got wet, smeared, or tore, or we sometimes find primary package labels missing or misaligned when we do repack projects and they usually have us toss it because it doesn't happen very often or with large quantities.  We don't inspect labels, unless specifically asked to do so as a special project, it's just if we notice it we report it.