FDA 483 Citations for Dietary Supplement Label and Packaging Specifications Under 21 CFR 111.70(d)

22 hours ago

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"You did not establish [label] [packaging] specifications." FDA investigators cited 21 CFR 111.70(d) with that wording 47 times on system-generated Form FDA 483s in fiscal year 2025.

Labeling mistakes cause many dietary supplement recalls: the wrong label on the right bottle, an old label with an outdated claim, or a Supplement Facts panel that does not match the formula. Packaging matters too, because bottles, liners and desiccants that react with or let moisture into the product can change its strength and stability. Specifications are where control of both begins.

What the citation means

Examples written after "Specifically" usually describe:

No specifications for labels, so there is no approved version to check incoming labels against
Labels received and used without comparing them to approved artwork
No specifications for bottles, caps, liners, seals or desiccants
Packaging changed to a new supplier or material without assessment
Packaging that contacts the product with no evidence that it is safe and suitable
Label versions not controlled, with obsolete labels still in stock

What Part 111 requires

Specifications (111.70(d)). You must establish specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications). Packaging that may come into contact with dietary supplements must be safe and suitable for its intended use and must not be reactive or absorptive or otherwise affect the safety or quality of the dietary supplement.

Receiving labels and packaging (111.160). You must visually examine each immediate container or grouping of immediate containers in a shipment for appropriate content label, container damage or broken seals, quarantine them until quality control approves them, and identify each unique lot.

Packaging and labeling operations (Subpart L, 111.403 to 111.430). You must establish and follow written procedures for packaging and labeling operations, including procedures to ensure that you use the packaging and labels specified in the master manufacturing record, to examine labels and to reconcile the quantity of labels issued, used and returned, and to control the issuance of labels.

Label content itself must also meet FDA labeling rules, including 21 CFR 101.36 for the Supplement Facts panel.

How to respond to the 483

Part 111 does not set a deadline for responding, but most firms respond in writing within 15 business days of the close of the inspection, so FDA has the response before it decides on further action.

Write label specifications

For each label, the specification should identify the approved artwork and version, and the key attributes to check on receipt: product name, Supplement Facts content, ingredient list, net quantity, allergen statement where required, lot and date areas, barcode, dimensions and material.

Write packaging specifications

For each container, closure, liner, seal and desiccant, define the material, dimensions and supplier, and the evidence that it is safe and suitable, such as food-contact compliance statements and stability data in that packaging.

Check what is in stock and on the market

Compare labels in inventory with approved artwork and destroy obsolete versions. Review recent lots for label mix-ups. Where packaging was changed without assessment, review stability and complaints.

Control labeling operations

Quality control approval of labels on receipt
Secure storage and controlled issuance of labels
Line clearance between products
Label examination during packaging
Label reconciliation for each lot, with limits and investigation of discrepancies

What compliant label and packaging controls contain

Label specifications tied to approved artwork
Packaging specifications and suitability evidence
Artwork review and approval, including regulatory review of claims
Receiving examination and quarantine
Label storage, issuance and destruction of obsolete stock
Line clearance and label examination
Label reconciliation
Change control for labels and packaging

Common mistakes in label and packaging responses

Writing a specification that only says "per artwork" without defining what is checked
Ignoring packaging that contacts the product
Leaving obsolete labels in stock
Skipping label reconciliation for short runs
Changing bottle or desiccant suppliers without a stability assessment

Example: how one response section might read

This illustrates structure only; your response must describe your own facts.

Observation 11: You did not establish label and packaging specifications. Specifically, no specifications exist for the labels or HDPE bottles used for the probiotic capsules.

Response:

Correction: Label and packaging specifications were approved by quality control on a stated date. The bottle specification includes the resin, dimensions, moisture barrier and supplier, and the desiccant specification includes type and quantity.
Inventory check: Labels in stock were compared to approved artwork, and two obsolete versions were destroyed.
Stability: Ongoing stability data for the product in the specified bottle supports the labeled count through the shelf life.
Corrective action: Receiving now checks every label lot against its specification, and each packaging lot includes label reconciliation reviewed by quality control.

Frequently asked questions

What should a label specification include?

Enough to verify that the label received and applied is the approved one: artwork version, key text elements, dimensions, material and print quality attributes.

Does packaging that does not touch the product need a specification?

Section 111.70(d) covers packaging that may come in contact with the dietary supplement. Outer cartons are often controlled too, as part of labeling.

Is label reconciliation required?

Subpart L requires procedures for packaging and labeling operations, including controls that ensure the correct labels are used. Label reconciliation for each lot is a standard way to meet that.

How A.P. Lyon documents help

A.P. Lyon's Dietary Supplement cGMP Quality System (21 CFR 111) includes label and packaging specification forms, receiving, label control and reconciliation procedures. The Supplement Brand Owner Compliance Pack covers label approval for brand owners whose products are packaged by others.

Documents are editable Word and Excel files and must be adapted to your products and operations. Label claims must be reviewed by qualified people.

Next steps

Write label and packaging specifications for every product
Remove obsolete labels and check recent lots
Control label issuance, examination and reconciliation
Respond in writing within 15 business days with dates for each action

To compare the complete system with the brand owner pack, see all dietary supplement documents.

Not sure where your quality system stands? Take the free QMS gap check: about 20 questions, an instant report of your gaps by clause, and the procedures that close each one.