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Food & Beverage AI agent · Recall clock

Recall & Reportable Food AI Agent

Stamp the hour each incident signal was received and the hour a determination was made, so the responsible party can file inside the window 21 U.S.C. 350f leaves open.

Typical delivery
4–6 weeks
Deployment
Your stack
Person decides
Clock-bound
After launch
Agent Care

What this agent does

Stamps the hours, never the determination

In

  1. 01

    A finding is made, and 21 U.S.C. 350f allows twenty-four hours from that determination.

  2. 02

    A complaint arrives, and the hour of receipt is stamped though no clock has started.

Reason

  1. 03

    A finding is weighed, and § 350f asks whether serious harm is reasonably probable.

  2. 04

    A determination stands, and the responsible party is the registrant under § 350d(a).

  3. 05

    A finding touches infant formula, and § 350f carves that one article back out.

Decide

  1. 06

    A consignee level opens, and § 7.42(b)(3) runs levels A through E, where E is none.

  2. 07

    A recall runs on, and § 7.53 wants status reports every two to four weeks.

Out

  1. 08

    A recall plan is read, and § 117.139 sits inside the plan signed under § 117.310.

  2. 09

    Execute write actions only inside the approval boundaries agreed during implementation.

Product statement

The agent stamps the hours and assembles the file. A named person determines that a food is reportable, and FDA classifies the recall under § 7.41(b).

Example workflow

One finding, signal to determination

  1. 1Incident signals receivedComplaints, environmental monitoring hits, supplier certificates or laboratory results
  2. 2Finding context assembledThe lot, the hour each signal landed, the distribution already made and the plan on file
  3. 3Determination file draftedThe signals, their hours, the check population and completeness
  4. 4Controls appliedClock checks, consignee-depth checks, element checks against § 350f and completeness confidence

No human action required

Stages 1 to 4 run unaided, and nothing is determined at any of them — the agent is assembling, and the recall lane opens at the completeness gate.

5DecisionSplits at the completeness gate
Evidence sufficient

Goes to the responsible party to determine.

Anything thin

Adds a quality director read first.

Recall review

The file is held with its signals, their hours and the distribution behind them.

Determine · Append evidence · Send to recall review

Determined — twenty-four hours run from here

  1. 6Recall and lot records updatedOnly where write access and records policy allow it
  2. 7Outcome evaluatedDetermination latency, consignee coverage, reviewer corrections and what the read found

Corrections

Each recall correction is counted in the evaluation.

What should not run autonomously

Human approval stays in control

Outside the boundary — human approval required

8 items

  • Determining that a food is reportable, § 350f.
    • Filing the report through the electronic portal.
    • Classifying a recall — § 7.41(b) leaves that to FDA.
    • Signing and dating the food safety plan, § 117.310.

  • Automation boundary

    Agent acts unaided

    • ✓Stamp the hour each incident signal was received on the record.
    • ✓Time the determination apart from the signals that led up to it.
    • ✓Build the distribution depth by consignee level.
    • ✓Flag the finding whose hour the record cannot show.

    Nothing is determined, filed or classified except by a named person or by FDA itself.

    • Choosing the effectiveness-check level under § 7.42.
    • Requesting termination of a recall under § 7.55.
    • Answering a cease-distribution order within two days.
  • Changes to lot, consignee or distribution records.

Example output

One finding, annotated

No signature falls due per recall event; this record is what one finding carried while nobody had yet determined anything.

Recall evidence · single finding

Illustrative example
Finding
Consumer complaint, § 350f
Recorded as
Received in the shared mailbox, no determination yet made
Signal class
Complaint signal
Evidence of record
Received 3 August 2026, hour stamped
Confidence
Held undetermined
Held for
The responsible party, by name

As received

Taken from the complaint intake and the distribution list — it reaches as far as those sources do.

What the record holds

  • Complaint intake log
  • Distribution list
  • Determination note

Why no determination here

Whether a food is reportable is a § 350f judgement reserved to a person.

What the score decides

Below the configured threshold the file picks up a recall read before it moves.

Action

DetermineAppend evidenceSend to recall review

Value

Where AI adds value

The same four claims, placed at the point in the workflow where each one applies.

Where the value lands

Value 01 – 04

Every finding

From the channel that raised it

03Evidence

Where the evidence is used

Our supply-chain traceability agent owns the lot graph and hands a named person the release decision, and its own duty is deferred to 20 July 2028 by Pub. L. 119-37 while the clock on this page is live today — what the two share is exactly the consignee list.

01Approved path

The clock starts on a finding

21 U.S.C. 350f runs from the moment a responsible party determines a food is reportable, and wants the report as soon as practicable inside that period.

02Human review

What was checked, and not found

No rule amending Part 7 Subpart C was located for 2024 to 2026 and no Unified Agenda check was performed, so nothing proposed here means nothing found rather than nothing existing; whether the Safety Reporting Portal presents an attestation at submission could not be verified, and § 7.42 was last amended at 88 FR 45064 on 14 July 2023.

04

Build an evidence trail

The finding, the hour it was made and the person who determined it stay on the record.

Integrations

Typical integrations

Five system groups connect to the same agent. Which of them are in scope is decided in discovery.

  • Complaint and consumer channels

    • Care inbox
    • call logs
    • Complaint intake records

  • Laboratory and monitoring

    • LIMS
    • environmental swabs
    • Certificates of analysis

  • Distribution and consignees

    • ERP
    • shipment records
    • Consignee and account lists

Agent

Recall and reportable food

  • Reads the signals
  • Stamps the hours
  • Holds for determination

  • Plans and procedures

    • Food safety plan
    • § 117.139
    • Written recall procedures

  • Observability & evaluation

    • OpenTelemetry
    • Langfuse
    • Supported monitoring/evaluation sources

Integration availability depends on the client's existing systems and API access.

Agent controls

Six cuts between the model and the determination

Six cuts at the same finding, each one sharper. Whatever holds through all of them is mapped out below.

L6 · Outermost — last line of defence

Inward → L1 · closest to the model

L6Rollback / safe modeNarrow the agent to evidence assembly when evaluation or production signals degrade.Roll back
L5Version monitoringTrack model, prompt and clock rules; no amendment to Part 7 Subpart C was found for 2024 to 2026, and the FDA letter to industry of 15 December 2025 is a letter and not a rule.Track
L4Hour trailRecord each signal, the hour it landed, the hour of determination and every read of the file.Record
L3Determination gateHold the file for the responsible party registered under § 350d(a); the hold governs release, not whether the article is reportable.Gate
L2Scope guardrailsTest the file against §§ 350f, 7.42 and 7.53; a mandatory recall under § 350l follows a refused voluntary one, and § 350l(h) leaves that order to the Commissioner alone.Restrict
L1Confidence thresholdsRoute a thin file to a recall read first; the December letter presses on speed and restates § 117.139(b)(3) effectiveness checks.Require review
Model coreFile assembled — the signals, their hours, the distribution and completeness
L1 – L2
Test whether a file may stand
L3
Puts the determination in a person's hands
L4 – L5
Keep the finding and the hour behind it
L6
Steps back to evidence assembly when signals degrade

How Nestack evaluates it

Evaluate the whole assembly — not only the determination file that comes out.

Coverage runs the whole depth of the workflow, and every layer is cut by slice.

Surface — the file an investigator reads

  1. E1Final-output evaluationDid the file carry the hour each signal actually landed?
  2. E2Step-level evaluationDid the agent read the right lot, the right consignee level and the live distribution?
  3. E3Tool evaluationDid it read and write the correct finding record and the correct hour?
  4. E4Confidence calibrationDo low-confidence files actually attract more recall corrections?
  5. E5Slice evaluationHow does performance change across specific signal channels?
  6. E6Business outcomeHow many files needed a correction before the determination was made?

Floor — the record the firm answers for

Failure modes

Where each failure originates in the agent

Seven failure modes, each placed at the stage where the clock first slips.

Agent lifecycle

Direction of processing →

  1. 01 · Retrieval

    1 mode

    • JS-03

      Stale distribution read

      The consignee list read is not the one now in force.

    Stage gathers

    The signals, the hours, the lots and the lists

  2. 02 · Reasoning

    2 modes

    • JS-04

      Hour asserted, not shown

      A determination hour is stated with no record beneath it.

    • JS-06

      Guidance read as rule

      The recall guidance is worked as though binding.

    Stage proposes

    The findings, their hours and completeness

  3. 03 · Tool / write

    2 modes

    • JS-02

      Thin file passed forward

      A file moves on without the recall read.

    • JS-05

      Signal bound to wrong lot

      A record is filed against the wrong lot.

    Stage writes

    Only where write access and approval policy allow it

  4. 04 · Output

    1 mode

    • JS-01

      Determined, hour unrecorded

      The file shows a determination but not its hour.

    Stage returns

    The file a named person reads before determining

  5. 05 · Change / Version

    1 mode

    • JS-07

      Silent clock regression

      A configuration change moves the clock, not the record.

    Stage tracks

    Model, prompt, clock rules and evidence fields

  • Sev-1 · a determination made on no record
  • Sev-2 · wrong hour reaches the file
  • Sev-3 · source degrades, file holds open
See the complete Food & Beverage failure-mode catalogue

Affected slices

Consumer complaints absorb the corrections

A finding-level determination-latency figure can read clean while consumer complaint channels carry most of the rework. Nestack reports the correction rate by signal channel, not only in total.

Slice performance — reported separately, not only in aggregate

Illustrative example
SliceFailure rateLiftLift vs. thresholdStatus
Consumer complaint channels7.4%3.6×Review
Environmental monitoring hits5.3%2.6×Review
Supplier certificates of analysis3.3%1.6×Watch
In-house laboratory results1.3%0.6×Normal

Bar: correction-rate lift vs. in-house-laboratory baseline · scale 0–4.0× · tick marks the 2.0× review threshold

2 of 4 slices over threshold

Evidence-linked improvement

What a late determination costs

A loop ends when the late determination has become a case the next release must pass. That suite is what the next finding logged is measured against.

Improvement cycle · five stages

Switchback — the path turns at Improve and returns at Learn

  1. 01

    Detect

    Correction rate rises on consumer complaint channels.

  2. 02

    Diagnose

    The complaint that sat in a shared mailbox while a statutory day ran is opened again until one cause remains.

  3. 03

    Improve

    Number the change; the findings that drove it are filed underneath it.

  4. 04

    Verify

    Each touched finding case is run once more, and one red holds it back.

  5. 05

    Learn

    It stays on as a standing test, and the escalation rules move with it.

  6. Learn → Detect

    The return edge. The next finding is measured against a suite one case longer.

Typical build scope

Twelve workstreams across six weeks

The build scope read against the delivery timeline. Week structure follows the six-week plan — discovery, sources, evidence assembly, evaluation, integration, then production validation and handover.

Workstream

Week 1Week 2Week 3Week 4Week 5Week 6

  1. 01Recall-clock discovery and automation-boundary work.Week 1
  2. 02Complaint, lab and distribution sources.Week 1, Week 2
  3. 03Signal-to-determination and consignee-depth mapping.Week 1, Week 2
  4. 04Incident signal ingestion.Week 2
  5. 05Finding, hour and lot binding.Week 2, Week 3
  6. 06Completeness scoring and review routing.Week 3
  7. 07Responsible-party determination flow.Week 3, Week 4
  8. 08Recall and lot-system integration.Week 5
  9. 09Determination and check cases.Week 4, Week 5
  10. 10Guardrails and escalation controls.Week 4
  11. 11Finding-trail instrumentation.Week 5, Week 6
  12. 12Deployment, documentation and Agent Care handover.Week 6

12 workstreams · 6 weeks · bar shows the weeks a workstream is active — several run in parallel

Final scope and sequence confirmed in discovery

Engagement tiers

What each tier includes

Rows are the capabilities named in each tier's scope. Higher tiers include everything below them.

Capability✓ in scope · — not at this tierPilotOne site, one recall laneProductionProduction recall workflowAdvancedMultiple sites / brands
Introduced at Pilot
Evidence assembly to your channels✓✓✓
Responsible-party determination✓✓✓
Distribution-depth baseline✓✓✓
Introduced at Production
Reporting by consignee level—✓✓
Determination workflow in your systems—✓✓
Approved write-back—✓✓
Complaint-channel integration—✓✓
Introduced at Advanced
Multi-brand recall plans——✓
Cross-channel evidence packs——✓
Large consignee lists——✓
Multi-clock notification controls——✓
Build priceFrom $5,000From $8,000Custom quote
Final build price
Confirmed after discovery based on integrations, workflow complexity, consignee list size, approval controls and deployment requirements.
Separate from build
Build pricing is separate from recurring Agent Care, which covers managed monitoring, evaluations, incidents and verified improvements after launch.

What we need from you

What you bring, and what we build with it

Each input maps to a piece of build scope and a week in the delivery timeline.

  1. 01Your registered facilities and their signal channels

    Channel mapping and hour capture

    Week 1

  2. 02Representative complaints, results and distribution records

    Record binding, clock logic and the evidence baseline

    Week 2

  3. 03Your written recall plan under § 117.139

    Channel mapping, hour stamping and the automation boundary

    Week 1

  4. 04Access to relevant APIs, feeds or exports

    Complaint, laboratory and distribution-source assessment, then integration setup

    Week 2

  5. 05Findings you would not want examined

    Determination cases and failure testing

    Week 4

  6. 06What no recall record may prove

    Completeness scoring, review routing, guardrails and release controls

    Week 3

  7. 07A responsible party named to determine

    Determination workflow, then pilot and production validation

    Weeks 5–6

Nothing else is required

Deployment, documentation and Agent Care handover are ours.

Delivery timeline

Four phases across six weeks

The spans below are honest working weeks rather than spacing, so two of them must share week five.

Phase

W1

W2

W3

W4

W5

W6

  1. DiscoveryW1
  2. BuildW2 – W3
  3. EvaluateW4 – W5
  4. Pilot & LaunchW5 – W6

Week focus

W1Recall workflow discovery, channel mapping and the automation boundary

W2Source integration and the distribution-depth baseline

W3Evidence assembly, clock logic and release controls

W4Evaluation suite, determination cases and failure-mode testing

W5Record integration, pilot findings and targeted corrections

W6One recall exercise run under the quality director, then Agent Care handover

Reading the band
Every bar runs across the weeks its own work is named in, and the fifth holds two of them because that is what the work costs.
At the end of W6
When the finding record validates, Agent Care takes the agent on.
Duration
Six-week plan shown · typical delivery 4–6 weeks depending on scope confirmed in discovery.

Next step · Food & Beverage AI agent

Build a recall agent around the hour your own people made the call.

The law gives a clock and no ceremony. Show us your complaint channel, your distribution lists and the plan a named officer signed under § 117.310. What can be asked for afterwards is the record of when you knew. CPSC product safety reporting is a different agent.

Typical delivery
4–6 weeks
Deployment
Your signal channels
Person decides
Clock-bound
After launch
Agent Care available

Nestack Agents · Recall clock

AGT-FB-18 · Agent Care available after launch

Build a recall agent

Four questions so the call starts from your actual setup — then pick a time that suits you.

About you
Your findings

No obligation. We’ll map the workflow, name the automation boundary and tell you if an agent is the wrong answer.