FDA 483 OBSERVATION · #57 OF 1,923 MOST-CITED

Signed and dated

FDA cited this observation 437 times across 402 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.

What this grouping is not

An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.

BY PROGRAM AREA
Foods437
BY FISCAL YEAR
FY202617
FY202516
FY202426
FY202336
FY202224
FY202122
FY202026
FY201958
FY201878
FY201771
FY201663

What this observation means, and how to comply

SPEQ's practitioner reading of this finding. The regulatory basis is a cited fact; the interpretation, compliance steps, and root causes are SPEQ synthesis — not an FDA classification of the citation.

Seafood 21 CFR 123.6(c) · Juice 21 CFR 120.8

The HACCP plan (or a required record) was not signed and dated as the regulation requires — the individual accountability and the timing of the record were not established.

Why FDA writes it — A signature and date establish who is responsible for the plan and when it took effect or was reviewed. An unsigned or undated HACCP plan lacks the accountability the rule requires, and undated records break the timeline that demonstrates control.

HOW TO COMPLY
  • Ensure the HACCP plan is signed and dated by the most responsible individual on-site or a higher-level official, upon initial acceptance, upon modification, and upon reassessment.
  • Sign and date required monitoring, corrective-action, and verification records as they are made.
  • Use dating that establishes contemporaneity, not after-the-fact completion.
  • Keep signatures attributable to identifiable individuals.
WHY FIRMS GET CITED
  • A HACCP plan or record left unsigned or undated, removing accountability and timing.
  • Records dated in batches rather than at the time of the activity.
PROFESSIONAL · REMEDIATION PLAYBOOK · SPEQ SYNTHESIS

How to close this finding — and stop it recurring

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What this observation is associated with

Firms cited for this observation also appear in FDA compliance actions — warning letters, injunctions, or seizures — at 1.1× the rate of the average FDA-cited firm (8.2% vs 7.8%), across 402 FEI-matched firms.

This is an association, not causation, and reflects co-occurrence in FDA's records — not a claim that the observation caused or preceded the action.

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How FDA worded it — real examples

Your HACCP plan was not signed and dated upon modification and at least annually.

Pacific Seafood Eureka LLC · Eureka, California · Foods · 2026-08-26

Your HACCP plan was not signed and dated upon initial acceptance and at least annually.

Pacific Exchange Distributors, LLC · Gardena, California · Foods · 2026-07-30

Your HACCP plan was not signed and dated at least annually.

Fidemart Food, LLC · Tampa, Florida · Foods · 2026-07-30

Your HACCP plan was not signed and dated upon initial acceptance.

Marine Frozen Foods Company LTD · Samut Sakhon · Foods · 2026-06-25

Your HACCP plan was not signed and dated upon modification and at least annually.

HARBOR MARINE PRODUCT, INC. · Vernon, California · Foods · 2026-06-01

Your HACCP plan was not signed and dated at least annually.

Pujado Solano S.A. · Santona · Foods · 2026-04-07

Related SPEQ references

Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.

Food industry →

Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →