FDA 483 Citations for Implementing a Seafood HACCP Plan Under 21 CFR 123.6(b), 123.8 and 123.10

22 hours ago

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A good seafood HACCP plan does not help if it is not followed. In fiscal year 2025, FDA investigators recorded these observations about implementation on system-generated Form FDA 483s:

"You did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP plan," 123.6(b), 84 times
"No one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience," 123.10, 26 times
"Your process monitoring equipment is not calibrated to ensure that it reads accurately," 123.8(a)(2)(ii), 16 times
"You did not review [some of] your [critical control point monitoring] [corrective action] [calibration] [in-process testing] [end-product testing] records [within one week] [within a reasonable time] after the records were made," 123.8(a)(3), 13 times
"You did not take corrective action that ensured [affected product was not entered into commerce] [the cause of the deviation was corrected]," 123.7(a), 11 times

These findings tell FDA that the plan is a document on a shelf. Investigators compare monitoring records with the plan's frequencies, check thermometers, ask who reviewed the records and when, and ask to see the HACCP training certificate.

What the citations mean

Examples written after "Specifically" usually describe:

Receiving temperatures or cooler logs not recorded at the frequency in the plan
Records missing for whole days or shifts
Thermometers and data loggers never checked for accuracy
Records reviewed months later, or never
Critical limit deviations with no corrective action record
Product from a deviation shipped without evaluation
No one at the firm, or working for it, trained in seafood HACCP

What Part 123 requires

Implementing the plan (123.6(b)). Every processor must have and implement a written HACCP plan whenever a food safety hazard is reasonably likely to occur. Implementing means performing the monitoring, corrective actions, verification and recordkeeping exactly as written.

Corrective actions (123.7). When a deviation from a critical limit occurs, the processor must follow its corrective action plan or, if there is none, segregate and hold the affected product, perform or obtain a review to determine its acceptability for distribution, take corrective action to ensure no injurious or adulterated product enters commerce and to correct the cause, and reassess the plan. Corrective actions must be documented.

Verification (123.8). The processor must verify that the plan is adequate and effectively implemented, including:

Reassessing the plan at least once every 12 months and whenever changes occur (123.8(a)(1))
Reviewing consumer complaints relating to the operation of critical control points or possible critical limit deviations (123.8(a)(2)(i))
Calibrating process monitoring instruments (123.8(a)(2)(ii))
Periodic end-product or in-process testing, at the processor's option (123.8(a)(2)(iii))
Reviewing critical control point monitoring and corrective action records within one week of the day the records are made, and calibration and testing records within a reasonable time (123.8(a)(3))

Records (123.9). Records must include the name and location of the processor, the date and time of the activity, the signature or initials of the person performing it and, where appropriate, the identity of the product and the production code. Records must be retained for at least 1 year after the date they were prepared for refrigerated products and at least 2 years for frozen, preserved or shelf-stable products.

Training (123.10). The development of the HACCP plan, reassessment and modification of the plan, and record review must be performed by an individual who has successfully completed training in the application of HACCP principles to fish and fishery product processing at least equivalent to that received under a standardized curriculum recognized as adequate by FDA, or who is otherwise qualified through job experience. The trained individual need not be an employee.

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 produced without monitoring or after deviations

For periods with missing records or unaddressed deviations, evaluate the product using other evidence, such as other temperature records, testing or supplier data. Hold, test or destroy product as needed and decide whether a recall is needed.

Get HACCP training in place

Enroll at least one person in a seafood HACCP course using the standardized curriculum, or engage a trained individual. Have that person reassess the plan and review records.

Make monitoring practical

If monitoring frequencies in the plan cannot be met, fix the process or the plan, not the records. Assign monitors for each shift with backups, and use forms that match the plan.

Calibrate and review

Calibrate thermometers and data loggers on a schedule and record the results. Review critical control point and corrective action records within one week, and sign and date the review.

Document corrective actions

For each deviation, record the product affected, its evaluation and disposition, and the cause and its correction.

What compliant HACCP implementation includes

Trained individual responsible for the plan
Monitoring forms that match the plan
Monitors and backups for each shift
Calibration schedule and records
Weekly record review
Corrective action records
Annual reassessment, signed and dated
Records retention by product type

Common mistakes in implementation responses

Changing the plan to match missing records instead of fixing the process
Training one person who then leaves, with no backup
Calibrating thermometers once and never again
Reviewing records at month end instead of within one week
Recording deviations without evaluating the product

Example: how one response section might read

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

Observation 3: You did not implement the monitoring procedures listed in your HACCP plan. Specifically, cooler temperatures for cooked crabmeat were not recorded on 11 days, and records were not reviewed.

Response:

Product assessment: Continuous data logger records were found for 9 of the 11 days and showed temperatures within critical limits. Product from the other two days had been sold and was past its shelf life; no complaints were received.
Corrective action: A data logger with an alarm now monitors the cooler continuously, with a daily manual check recorded on the monitoring form.
Training: The plant manager completed a seafood HACCP course on a stated date and now reviews records within one week.
Calibration: All thermometers are checked monthly against a reference thermometer, and records are kept.
Verification: The plan was reassessed, signed and dated on a stated date.

Frequently asked questions

Does the HACCP-trained person have to be an employee?

No. Under 123.10, the trained individual need not be an employee of the processor, but they must perform the plan development, reassessment and record review functions.

How quickly must records be reviewed?

Critical control point monitoring and corrective action records must be reviewed within one week of the day they are made. Calibration and testing records must be reviewed within a reasonable time.

How long must records be kept?

At least 1 year for refrigerated products and 2 years for frozen, preserved or shelf-stable products.

How A.P. Lyon documents help

A.P. Lyon's Seafood HACCP Program (FDA 21 CFR Part 123) includes monitoring forms, corrective action records, calibration logs, a record review procedure and a reassessment form, so your plan and your records match.

Documents are editable Word and Excel files and must be adapted to your plant and products. HACCP training must be obtained separately. A.P. Lyon does not provide food safety consulting or training courses.

Next steps

Assess product made without monitoring or after deviations
Train or engage a seafood HACCP-qualified individual
Calibrate instruments and review records within one week
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.

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