FDA 483 Citations for Seafood HACCP Plan Contents Under 21 CFR 123.6

22 hours ago

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FDA investigators reviewing seafood HACCP plans recorded these observations on system-generated Form FDA 483s in fiscal year 2025:

"Your HACCP plan does not list the food safety hazards that are reasonably likely to occur," 123.6(c)(1), 63 times
"Your HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards," 123.6(c)(2), 55 times
"You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur," 123.6(b), 40 times
"Your HACCP plan [does not list a critical limit that ensures control of one or more hazards] [lists a critical limit that does not ensure control of one or more hazards]," 123.6(c)(3), 40 times
"Your HACCP plan lists monitoring [procedures] [frequencies] that do not ensure compliance with the critical limit," 123.6(c)(4), 24 times
"Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) ...," 123.6(c)(5), 21 times
"You did not conduct, or have conducted for you, a hazard analysis ...," 123.6(a), 18 times
"Your HACCP plan was not signed and dated ...," 123.6(d), 16 times
Verification procedures not in accordance with 123.8(a), 123.6(c)(6), 16 times

Together these exceed 290 citations. They usually trace back to a hazard analysis that missed a hazard, such as scombrotoxin (histamine) in tuna or mahi-mahi, Clostridium botulinum in reduced oxygen packaged fish, or pathogen growth in cooked ready-to-eat products.

What the citations mean

Examples written after "Specifically" usually describe:

No HACCP plan for a product with a hazard reasonably likely to occur
A plan that omits scombrotoxin, parasites, pathogen growth, C. botulinum, allergens or environmental chemical contaminants
Receiving not listed as a critical control point for histamine-forming species
Critical limits that are vague, such as "fish is cold," or not supported by science
Monitoring once a day where conditions change by the hour
Corrective action plans that do not address affected product or the cause
A plan not signed and dated after changes or the annual reassessment

What 21 CFR 123.6 requires

Hazard analysis (123.6(a)). Every processor must conduct, or have conducted for it, a hazard analysis to determine whether there are food safety hazards reasonably likely to occur for each kind of fish and fishery product it processes, and identify the preventive measures that can be applied to control them. Hazards to consider include natural toxins, microbiological contamination, chemical contamination, pesticides, drug residues, decomposition in scombroid and other species where decomposition has been associated with a food safety hazard, parasites where the processor knows or should know that the fish may contain them, unapproved use of food or color additives, and physical hazards.

When a plan is required (123.6(b)). Every processor must have and implement a written HACCP plan whenever the hazard analysis reveals one or more food safety hazards that are reasonably likely to occur. The plan must be specific to each location and each kind of fish and fishery product, although products may be grouped where hazards, critical control points, critical limits and procedures are identical.

Contents (123.6(c)). The plan must, at a minimum:

List the food safety hazards that are reasonably likely to occur
List the critical control points for each hazard
List the critical limits that must be met at each critical control point
List the procedures, and frequency, used to monitor each critical control point
Include any corrective action plans developed under 123.7(b)
List the verification procedures, and frequency, under 123.8(a)
Provide a recordkeeping system that documents the monitoring of the critical control points

Signing and dating (123.6(d)). The plan must be signed and dated by the most responsible individual onsite at the processing facility or a higher level official, upon initial acceptance, upon any modification and upon verification of the plan under 123.8(a)(1).

FDA's Fish and Fishery Products Hazards and Controls Guidance is the main reference for identifying hazards and setting controls.

How to respond to the 483

FDA does not set a single deadline for responding to a food 483, but most firms respond in writing within 15 business days, so FDA has the response before it decides on further action.

Assess product made under the plan

If a hazard was not controlled, evaluate product produced and in distribution, test where appropriate and decide whether a recall is needed.

Redo the hazard analysis

Have a HACCP-trained individual redo the hazard analysis for each product, using the FDA Hazards Guide tables by species and process. Document why each hazard is or is not reasonably likely to occur.

Rewrite the plan

For each hazard, set critical control points, measurable critical limits with a scientific basis, monitoring procedures and frequencies, corrective action plans that address product and cause, verification and records.

Sign, date and implement

Sign and date the plan, train monitors and start keeping records.

What a compliant seafood HACCP plan contains

Hazard analysis by product and process
Hazards reasonably likely to occur
Critical control points and critical limits
Monitoring: what, how, frequency, who
Corrective action plans
Verification: calibration, record review, testing, reassessment
Records
Signature and date

Common mistakes in seafood HACCP plan responses

Copying a generic plan that does not fit the species or process
Missing receiving controls for scombroid species
Setting critical limits without a scientific source
Writing corrective actions that do not address affected product
Forgetting the annual reassessment and signature

Example: how one response section might read

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

Observation 2: Your HACCP plan does not list the food safety hazards that are reasonably likely to occur. Specifically, the plan for fresh yellowfin tuna loins does not list scombrotoxin (histamine) formation.

Response:

Product assessment: Histamine testing of lots in inventory was completed on a stated date, and all results were below the FDA guidance level.
Hazard analysis: The HACCP-trained individual redid the hazard analysis using the FDA Hazards Guide on a stated date.
Plan revision: Receiving and cold storage were added as critical control points, with critical limits for harvest vessel records or internal temperature, sensory examination and histamine testing, and storage temperature with continuous monitoring.
Corrective actions: Lots failing receiving limits are rejected or tested, and the cause is addressed with the supplier.
Signature: The revised plan was signed and dated by the plant manager.

Frequently asked questions

Does every seafood processor need a HACCP plan?

Every processor must conduct a hazard analysis. A written HACCP plan is required whenever the analysis shows a hazard reasonably likely to occur, which is true for most products.

Who can write the plan?

An individual trained in seafood HACCP under 123.10 must develop the plan, reassess and modify it, and review records.

How often must the plan be reassessed?

At least once every 12 months and whenever a change occurs that could affect the hazard analysis or alter the plan, under 123.8(a)(1).

How A.P. Lyon documents help

A.P. Lyon's Seafood HACCP Program (FDA 21 CFR Part 123) includes hazard analysis worksheets, a HACCP plan form with every 123.6(c) element, corrective action and verification procedures, monitoring forms and a sanitation program.

Documents are editable Word and Excel files and must be adapted to your species, processes and plant. A HACCP-trained individual must develop and approve your plan. A.P. Lyon does not provide food safety consulting or prepare HACCP plans.

Next steps

Assess product made under the incomplete plan
Redo the hazard analysis with the FDA Hazards Guide
Rewrite, sign and implement the plan
Respond in writing within 15 business days with dates for each action

See all HACCP programs, including seafood, juice, meat and poultry, and restaurant programs.

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.