FDA Warning Letter Monitor - Supplier & Closeout Changes

SOURCE COVERAGE & PRACTICAL LIMITS

Full product guide

Documentation captured from build 1.0.1. Example outputs retain their original sample context; they are not live results.

FDA Warning Letter Monitor

Turn FDA's warning-letter table into a repeatable supplier-review feed. Collect company names, published subjects, dates and original document links, then compare later observations to find new records and changed response or closeout links.

Coverage: one selected window of up to 100 FDA table records per run. Filters apply inside that window. This monitors published records; it does not decide whether a supplier is compliant, whether allegations are proven, or whether an issue remains unresolved.

Start with five recent letters

{
  "sortBy": "postedDate",
  "maxSourceRecords": 25,
  "maxResults": 5
}

Run the Actor, then open Saved observations, Run report or CSV export in Output. No API key, login or proxy setup is required. FDA currently requests a 30-second crawl delay; the Actor honors it before its single table request. Allow at least 90 seconds of platform timeout. Typical successful local checks take about 32 seconds; availability can vary.

Cost: $0.003 per saved letter observation at the FREE/BRONZE base rate, plus $0.00005 per Actor start. Five rows cost $0.01505 in Actor events. SILVER and GOLD+ rates are lower; check the Store's current Pricing tab for your plan. An unchanged observation is still a saved, charged row unless onlyChanges is enabled. Errors and skipped unchanged rows are not paid result rows. Platform charges, where applicable, are separate.

What you get

• A spreadsheet-ready row per warning letter, with company, issuing office, subject, posted date and issue date.
• Distinct URLs and table-posted dates for a linked response and a linked closeout.
• Literal supplier-name or topic matches, with the matching field and a short excerpt.
• Saved comparisons: new, changed or unchanged, changed fields, prior values and prior observation time.
• A readable RUN_REPORT and machine-readable SUMMARY showing source bounds, filtering, saved rows and any errors or limits.

For example, this abbreviated record reflects an official closeout-window observation retained during development:

{
  "companyName": "Talla Imports, LLC",
  "marcsCmsId": "699044",
  "postedDate": "2025-02-04",
  "letterIssueDate": "2025-01-13",
  "subject": "Foreign Supplier Verification Program (FSVP)",
  "hasPostedResponse": false,
  "hasPostedCloseout": true,
  "closeoutPostedDate": "2026-10-05",
  "comparisonStatus": "not_requested"
}

The complete row also includes the original warning and follow-up links, source request, observation time and comparison fields. closeoutPostedDate is the date shown in FDA's table; it is not an inferred date from the document URL or a current compliance status.

Three ready-to-use workflows

1. Recently posted warning letters

Use the quick-start input above. It reads the first 25 records in descending posted-date order and saves at most five. Default {} uses the same window and saves up to ten.

2. Supplier-verification closeout updates

{
  "sortBy": "closeoutPostedDate",
  "maxSourceRecords": 25,
  "keywords": ["Foreign Supplier Verification"],
  "maxResults": 5
}

This looks for FSVP subjects within the 25 most recent closeout-link dates. It returns the underlying warning-letter records and their follow-up links. Dated entries may be followed by records with no linked closeout if the requested window extends beyond them.

3. A saved comparison for the recent window

{
  "sortBy": "postedDate",
  "maxSourceRecords": 25,
  "maxResults": 100,
  "comparePrevious": true,
  "onlyChanges": false,
  "snapshotName": "fda-latest-window"
}

The first run establishes history after each row is confirmed saved. Run the same input again to inspect prior values. Set onlyChanges to true to save only new or changed observations; a fully unchanged run correctly returns zero rows.

For a supplier watchlist, add companyNames, for example ["Eurofins", "Hanlim"]. Matching is a case-insensitive substring of the published company name, without entity resolution. A supplier outside the selected window will not be checked. The Actor does not search the complete archive for each supplier.

Input reference

Comparison and coverage rules

The stable row identity is letterUrl. The MARCS-CMS identifier is extracted only when it is present in that official URL; it is otherwise null. Comparison covers the company, dates, issuing office, subject and linked follow-up fields. Observation timestamps and match excerpts are excluded from change detection.

new means first saved observation in this comparison scope, not first FDA publication. FDA can return different records tied on a date at the source-window boundary, even when a secondary sort is requested. A repeat can therefore discover older, previously unseen records without a new FDA publication. Use postedDate and letterIssueDate for publisher chronology. Exact letter-URL watchlists are not supported.

History advances only for confirmed saved rows. Existing observations outside a later window remain stored. Nothing leaving a window is treated as a removal, withdrawal, resolution or clean bill of health. Use one sequential writer per identical history scope. The Actor rereads history before committing and refuses a known conflict, but this is not an atomic multi-writer store. Incompatible history is left untouched; choose a new namespace.

sourceWindowHasMore indicates records beyond the selected window. sourceWindowComplete means the requested window was successfully fetched and validated, not that the archive was complete. stoppedOnMaxResults is a deliberate output cap; status: "ok" can accompany that cap. Time, spending, history or source failures are separately marked as incomplete. Always inspect the report before treating an empty dataset as meaningful.

Source context and limits

The source is FDA's public Warning Letters table, including the same public JSON table transport used by that page. This transport is not advertised as a versioned public API and may change. The Actor validates the entire returned window before saving rows and stops on inconsistent counts, links, dates or ordering.

FDA identifies warning letters as a resource for firm and supplier evaluation under FSMA. FDA also explains the distinction between warning and closeout letters. Subsequent interactions may change the regulatory status of matters in a letter. A missing published response does not show that a firm failed to respond. A closeout is a specific published FDA follow-up, not a universal supplier certification.

The Actor does not fetch letter bodies, attachments, contact details, inspection reports, import-alert lists or response/closeout document text. Source updates and posting can be delayed. This is published-record monitoring for human review, not legal or regulatory advice.

Troubleshooting and support

• No rows: check the selected window, literal filters and unchangedSkipped before widening the source window.
• Time limit: use at least a 90-second platform timeout and keep enough time for FDA's crawl delay. Short budgets do not skip that delay.
• 403, 429, invalid source or robots refusal: the Actor stops without retries or bypass. Retry later after reviewing SUMMARY; the failed request produces no paid result rows.
• History conflict: schedule sequential runs or assign a separate store/namespace. Do not reset another workflow's history.

For support, open an issue on this Actor's Store page with the run URL and a redacted input. Do not include credentials or private supplier notes.