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Lot Coding Individual Bulk Items

Started by , May 20 2021 02:45 PM
3 Replies

Hello All! Does anyone know if items sold as bulk need to be individual lot coded or will the bulk-case lot code label suffice? We are manufacturing and packing bars as bulk which are then sent to schools for lunches. The bulk case is labeled with all the pertinent information including the lot code. Because they aren't sold as individual product but as part of a lunch is this compliant?

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No idea on the US reg position, but logically it would potentially seem sensible to add some sort of lot code or traceability info to each pack?

If a child finds a bolt in their bar (just as a hypothetical - not meaning to imply this would happen at your site!), how does the school know what the relevant batch code is to feed back to you for investigation? They may have multiple boxes on site, possibly several boxes of the different batch codes open at the same time etc.

Or they've taken them out of the box to put into serving displays etc, have several batches on the go, and a recall is issued - how do they know which bars are from which batch?

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We use sub-lot codes, thus allowing for full trace and ability to single out if a situation is only 1 sub lot and not the whole thing.

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Right now the school does not have any on hand. This is NOT something we normally do. normally our individual products are lot coded but due to an ordering issue we did not receive the ribbon we need to be able to print on the packaging so we are having to go with out. I was thinking because we normally lot code everything  we have a deviation statement addressing this issue as well as a corrective action that if something were to happen we would be able to still trace it due to the lack of the lot code as well as the school does not have any on hand to mix with. 

 

Thoughts?


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