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For quality and supplier-quality leads at medical device and pharma manufacturers. The pilot is being prepared. Review the sample before applying.
Review a sample digestWhen a public FDA record changes between supplier reviews, the proposed watchlist identifies the supplier and site. A daily digest shows the change and its source. You decide whether to ask for an explanation or bring a review forward.
You confirm company names, aliases and facility FEIs before checks start. Each supplier gets a baseline so existing records do not arrive as new activity. Unresolved suppliers stay visibly unmonitored.
Inspections can be NAI (no action indicated), VAI (voluntary action indicated), or OAI (official action indicated). VAI and OAI records warrant review. They do not provide an automatic supplier score.
Dashboard citations are not a complete copy of every Form 483.
Public documents only. Full document extraction is outside the first pilot.
A general alert without a matching firm does not trigger a supplier event. Removal requires complete verified snapshots.
FDA drug-import debarment list
FDA food-import debarment list
Corporate subjects only. Individual debarments are outside the pilot.
This fictional digest shows the intended format, including a failed check and stale source. A live pilot digest will link to source records and a private supplier timeline. Quiet days will include a check receipt.
Synthetic sample. All supplier names, sites, records and dates below are fictional. Links open FDA source collections, not evidence of these events.
12 confirmed suppliers. 1 unresolved suppliers are not monitored.
Review the source before deciding whether to contact a supplier.
Synthetic Cedar site · fictional FEI 0000000001
Match: Buyer-confirmed company and site (synthetic)
Inspection classification changed from VAI (voluntary action indicated) to OAI (official action indicated). Bring the supplier review forward if the finding affects your supply.
FDA event date: 2026-08-12
Publication date: Not provided by this source
Detected: 2026-10-08 03:20 UTC
Source: FDA Data Dashboard inspections classifications
Synthetic River site · fictional FEI 0000000002
Match: Buyer-confirmed company and site (synthetic)
Warning letter newly found. Ask the supplier whether the cited process is used for your product. This is an older event, not an event that happened today.
FDA event date: 2026-09-15
Publication date: 2026-10-06
Detected: 2026-10-08 03:20 UTC
Source: FDA warning-letter index
Failed or stale checks mean partial coverage. An empty result does not establish safety.
The pilot is for suppliers with an identifiable public FDA company or facility record. Some raw-material suppliers may have no matching records.
FDA publication can lag the event. Daily checks will compare locally refreshed records, not promise same-day FDA publication coverage. Each digest will show the last successful refresh for each source. A failed or stale source means partial coverage.
Public records exclude private supplier documents, non-public inspections and non-FDA regulators. Form 483 publication is incomplete. Product approvals, labels, adverse events, shortages and import-refusal alerts are outside this pilot.
No matching records does not establish safety. The watchlist does not approve suppliers, certify compliance or replace your supplier-quality process. RegDataLab is independent of the FDA.
$199 USD a month · up to 25 suppliers
Five pilot slots. One buyer account, confirmed sites, daily checks, an email digest, optional ntfy notifications and private timelines. A confirmed supplier group counts once, including its confirmed sites. Month-to-month, with no lookup credits or event fees.
The paid pilot starts after the shadow-cycle gate: at least seven consecutive daily test cycles, replay checks for every trigger, and verified matching, source freshness and delivery readiness. We will confirm coverage and the start date with you before payment.
Applying requests a fit review. It does not reserve a slot, start monitoring or create a subscription. API and MCP access remain a separate offer.
Tell us how you check critical suppliers today. We will review fit and coverage before agreeing on a paid start. Want to see real records first? Request a free snapshot for up to five suppliers.