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Guide

Produce repacking traceability: How to track original and finished lots.

A repack has to say which lots went in and which came out. Here’s when the finished lot needs a new code, when it can keep one, and what to write down.

Examples use made-up businesses and lot codes

The short answer

Under FSMA 204, repacking a food on the Food Traceability List is always a transformation (FDA FAQ TT.2). The repacker keeps a transformation record that lists the lots that went in, with how much was used from each, and the lot that came out, and becomes that lot’s traceability lot code source. Usually the finished lot gets a new code. If you repack a single lot “like into like”, with nothing mixed in, the FDA says you may keep its original code, but you still keep the transformation record, and the lot code source changes to you.

An example: 40 bulk cases into 80 retail cases

A repacker receives 40 cases of 25 lb red bell peppers from a grower, lot SVF-1021-RBP. It repacks them into 80 cases of twelve 1 lb bags. The 40 lb difference is culls and trim. The retail cases are a new lot, HLR-1026-07, and the repacker is now its lot code source.

The transformation record, 21 CFR 1.1350(a)
PartKey data elementIn this example
Food usedLot codeSVF-1021-RBP
Food usedProduct descriptionRed bell peppers, 25 lb bulk case
Food usedQuantity used from that lot40 cases
Food producedNew lot codeHLR-1026-07
Food producedWhere it was repacked (the new lot code source)Hillside Repack, its address and phone
Food producedDate the repack was completedOctober 26
Food producedProduct descriptionRed bell peppers, 12 × 1 lb bags a case
Food producedQuantity80 cases
Food producedReference document type and numberWork order RW-2291

The repacker also keeps a receiving record for the bulk lot and a shipping record for each customer the retail cases go to (FAQ TT.4). When it ships HLR-1026-07, it sends its own location as the lot code source.

See where each lot went

Three repacks, drawn as lots in, lots out and the customers who got them. Pick a lot coming in to see everything a recall of it would reach.

40 bulk cases become 80 retail cases

One incoming lot of bulk red bell peppers is repacked into 1 lb bags. The repack is a new traceability lot with a new code, and its record names the lot that went in.

Lots in

Lots out

HLR-1026-07Red bell peppers, 12 × 1 lb bags80 cases · Hillside Repack (fictional)

New code, assigned by the repacker. The repacker is now the traceability lot code source.

Shipped to

Corner Market30 cases of HLR-1026-07
Main Street Grocery35 cases of HLR-1026-07
Valley Café15 cases of HLR-1026-07

Pick a lot coming in to see everything it reached.

When more than one lot goes in

Mixing lots always means a new lot code. The FDA’s explanation is that a code shared by two lots would no longer identify a single lot (preamble Response 436). The transformation record lists every lot that went in, each with its product description and the quantity used from it (21 CFR 1.1350(a)(1)).

In the third example above, 10 cases of red peppers from one grower and 10 of green from another go into 60 cases of mixed trays. A recall of either grower’s lot reaches the whole tray lot and every customer who got it. That’s why it pays to keep quantities per input lot, and to avoid mixing lots you don’t need to.

You may read about a “reasonable range” of lot codes. The FDA has asked for comments on allowing a range of possible lot codes, or inferred ones, when foods ship from distribution to retail. As of October 26, 2026 it hasn’t decided, nothing has been adopted, and the idea isn’t about repacking.

Is it a transformation?

Common repack-room tasks under FSMA 204
TaskUsuallySource
Repacking bulk cases into retail packsTransformationFAQ TT.2
Sorting one lot by size into new packs (like into like)Transformation; may keep the lot codePreamble Response 436
Combining two or more lots into one packTransformation; needs a new lot codePreamble Response 436
Relabeling, including changing the brand on the labelTransformation21 CFR 1.1310; Response 308
Breaking a master case into separate shipmentsNot transformationResponse 307
Breaking a pallet to pull a caseNot transformation (draft guidance)Draft Q&A 19
Culling outside a repackNot transformation (draft guidance)Draft Q&A 20
An internal tracking sticker or pallet license plateNot relabeling (draft guidance)Draft Q&A 23

Rows marked “draft guidance” come from questions and answers the FDA published as a draft in February 2026. They show the FDA’s current thinking, but they aren’t final.

A repack routine

  1. Start a work order for each repack and give it a number. It’s the reference document.
  2. Scan or write down every lot that goes in, with the cases used from each.
  3. Decide the output lot code before you label. A new code by default; keep the original only for a like-into-like repack of one lot.
  4. Label the finished cases with the output lot code.
  5. Record the finished quantity and date when the repack is done, and note culls.
  6. Ship the finished lot with your location as its lot code source.
  7. Test it with a mock recall of one input lot: can you name every finished lot and customer it reached? Use the mock recall checklist

Common mistakes

  • Writing down the finished lot but not which lots went into it.
  • Keeping an input lot’s code after mixing in another lot.
  • Assuming every repack needs a new code, or that none does. It depends on whether lots are mixed.
  • Recording one lot when the line actually ran two, because the second was started partway through.
  • Keeping the old lot code source on a relabeled lot. After a transformation, you’re the source.

Why it matters

A repack is where one lot becomes several or several become one. If the link breaks there, a recall of one grower’s lot can’t be traced to the stores that got it, and the FDA can ask for these records within 24 hours (21 CFR 1.1455). As of October 26, 2026, the FDA is subject to a congressional direction not to enforce the rule before July 20, 2028. Read the FSMA 204 guide

How Clovero helps

In CloTrace, a repack gives the finished cases a new lot code and links it to every lot that went in, with the quantity used from each, so a trace runs from the grower’s lot to each customer. It prints GS1-128 case labels for the new lot. Keeping the original code for a like-into-like repack isn’t offered on screen today. See Clovero for packers and repackers

This guide is a summary of the FDA’s rule and its published answers as of the date above, not legal advice. Some businesses and foods are exempt or have modified requirements (21 CFR 1.1305).

Sources

Keep reading.

See how CloTrace tracks repacked lots.

Bring one repack: the lots that went in and the cases that came out. We’ll record it in CloTrace with you and trace it to the customers.

See CloTrace