Guide · First question

Ask Claude about a supplier’s FDA record.

Connect RegDataLab to claude.ai, paste one question, and Claude comes back with the company’s inspections, Form 483s, warning letters, recalls and import alerts, each with its date and a link to the FDA source. It takes about two minutes and 3 credits.

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A free account comes with 50 credits, and 300 a month once you verify your email. Already signed up? Your key is the one from signup; you can check it in your account.

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Connect Claude

In claude.ai, add RegDataLab as a custom connector. No install.

https://www.regdatalab.com/mcp

01Settings → Connectors → Add custom connector
02Paste this URL as the connector endpoint and choose OAuth sign-in
03On the RegDataLab page that opens, paste your API key once (or, for a verified account, choose Email me a sign-in link), then approve

Using Claude Desktop, Claude Code or Cursor instead? The setup for each is in the docs.

Ask the question

Start a new chat and paste this. Swap in any company you work with.

Your first question

Use RegDataLab to give me an FDA risk summary for Pfizer: recent inspections and their outcomes, warning letters, recalls and import alerts by site, with source links and dates.

Paste it into the chat once the connector shows as connected. A summary like this uses a few credits.

Claude calls fda_manufacturing_risk_summary, which reads the company’s whole family of sites in one call.

What comes back

This is what the tool returned for Pfizer on 29 October 2026, and what Claude summarises from it.

Pfizer · FDA record as of 29 October 2026 · 37 sites

Inspections: 240 on record: 101 NAI, 126 VAI, 13 OAI. Most recent closed 23 April 2026 at the Sanford, NC vaccines site (FEI 1000110954), classified VAI. One OAI in the last five years, on 18 February 2025.
Form 483s: Newest published: Hospira, McPherson, KS (FEI 1925262), issued 10 March 2026. Observation 1 cites process controls on a fill line. Form 483, Hospira McPherson, 10 March 2026
Warning letters: 8 across the family, most recent 25 March 2020 (Visakhapatnam, India, FEI 3008316085). None in the last five years.
Recalls: 613 distinct recalls, 37 in the last five years. Newest: D-0051-2027, Class II, reported 28 October 2026 (subpotent drug).
Import risk: 1 red-list import alert entry, dated 30 September 2009. 722 import refusals, of which 472 match by firm name only and are flagged as unconfirmed.
Debarments: None matched.

A Form 483 lists inspector observations. OAI means regulatory and/or administrative actions are recommended. A warning letter is FDA’s formal enforcement notice.

The raw response shape

{
  "company_resolution": { "company_id": "pfizer", "confidence": 0.95 },
  "newest_as_of": "2026-10-29",
  "facility_footprint": { "total_count": 37, "results": [ … ] },
  "inspection_summary": {
    "total_inspections": 240, "nai": 101, "vai": 126, "oai": 13,
    "last_inspection_date": "2026-04-23"
  },
  "recent_oii_records": [{
    "record_type": "483", "company_name": "Hospira, Inc.",
    "fei_number": "1925262", "record_url": "https://www.fda.gov/media/193551/download",
    "form_483_dates": { "issued_date": "2026-03-10" }
  }, … ],
  "older_warning_letters": { "total_count": 8, … },
  "import_risk": { "import_alert_count": 1, "import_refusal_count": 722, … },
  "recall_signals": { "unique_recall_count": 613, "last_ires_report_date": "2026-10-28", … },
  "integrity_signals": { "debarment_count": 0 },
  "highest_severity_signals": [ … ],
  "recommended_follow_ups": [ … ],
  "notable_gaps": [ … ]
}

Keep going

The same chat answers follow-up questions. A few that work well after the summary:

“List every Pfizer site with an OAI inspection and link each Form 483.”
fda_inspections
“Show the full facility list with FEIs, cities and countries.”
fda_search_family_facilities
“Give me the one-page dossier for FEI 1925262.”
fda_facility_dossier
“Put inspections, warning letters, recalls and import alerts on one timeline since 2021.”
fda_company_compliance_timeline

Who asks this question

Sales and business development

Know a prospect's recent inspections and recalls before the first call.

Suppliers and CDMOs

See your own public record the way your customers' quality teams see it.

Quality and procurement

Screen a new or existing supplier before an audit or a contract renewal.

Research and diligence

Pull a company's FDA history with sources for a memo or a model.

Get a free API key Or get a free supplier snapshot