FSMA 204 Transformation: When Repacking Creates a New Lot

Transformation is the critical tracking event most distributors discover late, usually because "transformation" sounds like manufacturing and their operation just repacks. It isn't manufacturing. If you break a supplier's lot into different cases, combine lots, or put your own label on someone else's product, you've transformed it — and under 21 CFR 1.1350 you now own a new traceability lot.

That shift matters more than the paperwork. Assigning a lot code makes you the lot code source. Everyone downstream traces back to you, not to the farm.

What triggers transformation

The rule doesn't publish a checklist of qualifying activities, so the working test is whether the output is a different traceability lot than the input. In produce distribution that usually means:

• Repacking — bulk or master cases broken down into retail packs or new case configurations
• Commingling — combining product from two or more supplier lots into one unit
• Re-labelling — applying your own brand or case label to product you didn't pack
• Creating mixed products — a variety pack or medley built from separate FTL inputs

Moving cases from one pallet to another isn't transformation. Neither is holding, cooling, or shipping. The traceability plan rules are explicit that you must not create a new lot code just because you performed another activity like shipping — new codes belong to transformation and initial packing, not to routine handling.

If your operation only stages and reships sealed cases as received, you're a receiver and shipper, not a transformer. That's a meaningfully lighter obligation, and it's worth confirming rather than assuming either way.

What the records must contain

Section 1.1350(a) splits the requirement in two: what went in, and what came out. Both link to the new lot.

For each FTL food used as an input:

#	Key data element
1	The traceability lot code for the food
2	The product description for the food that code applies to
3	For each lot used, the quantity and unit of measure taken from that lot

For the food produced:

#	Key data element
1	The new traceability lot code
2	Location description for where you transformed it (the TLC source), and TLC source reference if applicable
3	The date transformation was completed
4	The product description
5	Quantity and unit of measure (6 cases, 25 RPCs, 200 pounds)
6	Reference document type and reference document number

The input side is where commingling gets expensive. "For each traceability lot used, the quantity and unit of measure of the food used from that lot" means a mixed pallet built from four supplier lots needs four input records, each with its own quantity, all linked to the single output lot. That is a real operational constraint, not a filing detail — you have to know how much came from which lot at the moment you build it, because reconstructing it afterward from receiving totals doesn't work.

The exception worth knowing

Paragraph (b) covers transforming a raw agricultural commodity that had not been initially packed before you transformed it. In that case you're standing in for the initial packer, and the initial packing records under § 1.1330 apply instead — including harvest and cooling information. Sprouts carry additional requirements.

Paragraph (c) exempts retail food establishments and restaurants, but only for foods they don't ship. Sell it to a consumer and the transformation records don't apply; ship it to another business and they do.

Why this makes labelling your problem

Once you assign a new lot code, that code has to travel on the case. A code that exists only in your WMS doesn't help the buyer who receives it, and their receiving records under § 1.1345 require the TLC and the TLC source — which is now you.

Practically, a repacker needs to print case labels carrying its own GTIN and lot code, with the lot encoded so it can be scanned at the receiving dock rather than keyed by hand. That is exactly the gap between "we repack" and "we can prove what we repacked."

FAQ

Does repacking bulk product into consumer bags count as transformation?

Yes. The output is a different traceability lot than the input, which is the test. You assign a new lot code and keep both the input and output records linked to it.

If I combine two lots of the same commodity, is that one new lot or two?

One new lot, with input records for each of the two source lots including how much came from each. The output is a single traceability lot with a single new code.

Do I need a new lot code when I move cases to a different pallet?

No. Repalletizing isn't transformation, and the rule specifically directs you not to create new lot codes for other activities such as shipping.

Who is the traceability lot code source after transformation?

You are. The location description for where you transformed the food is the TLC source, and downstream receivers will record it as such.

Does transformation apply if I only relabel, without opening the case?

Applying your own label creates a new lot in most operations, because the case can no longer be identified by the original packer's code alone. Confirm against your own labelling practice and document the reasoning in your traceability plan.