# Openfda

> FDA drug data via openFDA: adverse-event reports and safety-signal tools (FAERS search, event…

- name: io.github.pipeworx-io/openfda
- version: 0.1.5
- connection class: R0 (autonomous)
- trust: 97/100
- quality: –/100 (not scored)
- owner: not claimed
- descriptor: https://api.protogrid.dev/v1/servers/io.github.pipeworx-io%2Fopenfda
- tools: https://api.protogrid.dev/v1/servers/io.github.pipeworx-io%2Fopenfda/tools

**An agent can connect right now, no human step.** Remote endpoint, no authentication, reachable on the last probe.

## Connection (mcpServers)

```json
{
  "mcpServers": {
    "openfda": {
      "type": "http",
      "url": "https://gateway.pipeworx.io/openfda/mcp"
    }
  }
}
```


## Trust

- hygiene: 100
- liveness: 99
- freshness: 100
- provenance: 90
- drivers: +repository +namespace-matches-repo +website +reachable +uptime-98% +updated-4d-ago
- Derived from observable signals (official registry feed and our own credential-free probes); no code audit performed.

## Quality –/100 (not scored)

Not scored: fewer than three checks apply, usually because no remote answered a credential-free probe or the server is a local package.

### protocol: 75 (weight 25)

- warn `protocol.modern`: newest supported version is 2025-03-26; 2026-07-28 not supported, older versions are deprecated until 2027-07-28
- n/a `protocol.stateless`: only applies to 2026-07-28 servers
- pass `protocol.transport`: streamable HTTP
- n/a `protocol.list_ttl`: only applies to 2026-07-28 servers

### authorization: n/a (weight 15)

- n/a `auth.prm`, `auth.as_metadata`, `auth.cimd`: no remote uses OAuth
- n/a `auth.secret_in_url`: no templated URL

### tool hygiene: n/a (weight 30)

- n/a `tools.descriptions`, `tools.description_length`, `tools.schemas`, `tools.annotations`, `tools.directory_hints`, `tools.token_cost`, `tools.api_dump`: tool list unknown (behind auth, not probed, or empty)

### stability: n/a (weight 15)

- n/a `stability.changes`, `stability.rug_pull`: tool list unknown

### dependencies: n/a (weight 15)

- n/a `deps.known_vulns`, `deps.mcp_sdk_version`, `deps.resolvable`: no npm or PyPI package

- tools: unknown
- tools last changed: 2026-10-18T06:48:12.802Z
- badge: [![protogrid quality](https://protogrid.dev/badge/io.github.pipeworx-io/openfda.svg)](https://protogrid.dev/servers/io.github.pipeworx-io/openfda)
- Checks run on what our credential-free, read-only probes observe; tools are never called and no code audit is performed.

### Tool changes

- 2026-10-18 `fda_postmarket_risk_profile` removed
  - Combine a drug’s FAERS reporting profile, label warning fields, and FDA recall records for review routing. This is not a validated safety comparison, causal assessment, incidence estimate, or substitute for FDA communications and clinical review.
- 2026-10-18 `fda_application_history` removed
  - Retrieve one Drugs@FDA NDA, ANDA, or BLA application and return its products and chronological submission-action history. Submission codes require regulatory interpretation and do not by themselves establish approval scope, exclusivity, or current marketing.
- 2026-10-18 `fda_faers_trend` removed
  - Aggregate daily FAERS report counts into calendar months for a drug and optional reaction over a bounded date window. The reaction argument matches one whole MedDRA preferred term, so a broad word like "neuropathy" counts only reports filed under that exact term and not the specific terms containing it. Natural multi-word phrasing is resolved to MedDRA word order and disclosed; a term matching nothing is reported as unresolved rather than as zero reports. Trends reflect reporting activity, publicity, utilization, duplicates, and database updates—not incidence or changing clinical risk.
- 2026-10-18 `fda_faers_reaction_profile` removed
  - Summarize the most frequently co-reported FAERS reactions plus serious/non-serious report counts for a drug. Counts are spontaneous reports with duplicates, co-medications, and reporting bias—not event rates or proof of causation.
- 2026-10-18 `fda_faers_signal_summary` removed
  - Calculate report-level FAERS disproportionality routing metrics for one drug/reaction pair using a 2×2 reporting table. The reaction argument matches one whole MedDRA preferred term, so a broad word like "neuropathy" counts only reports filed under that exact term and not the specific terms containing it. Natural multi-word phrasing is resolved to MedDRA word order and disclosed; a term matching nothing is reported as unresolved rather than as zero reports. ROR/PRR are screening statistics—not incidence, causality, comparative drug safety, or an FDA safety conclusion.
- 2026-10-18 `fda_warning_letters` removed
  - Search FDA WARNING LETTERS — official enforcement letters FDA sends firms for violations (CGMP, adulterated/misbranded products, unapproved claims). Answers "has <company> received an FDA warning letter", "recent FDA warning letters about supplements/devices". By default `search` matches the RECIPIENT company the letter was issued to, so the answer is about that firm's own enforcement history; set match:"fulltext" to search the whole letter record instead, which also finds letters that merely mention a firm. Every row reports matched_field so a caller can tell "issued to" from "mentions". Covers the 3,680 letters fda.gov publishes from 2021 onward — recipient company, posted and issued dates, issuing FDA office, subject and a link to the full letter text — and, for a firm with nothing in that window, falls back to the FDA compliance-actions archive of older letters back to 2010, which gives the firm, place, product type and issue date but no document. Every row says which of the two it came from. Live, no caller credential needed.
- 2026-10-18 `fda_event_counts` removed
  - Aggregate adverse events by reaction type, patient age, or outcome. Returns top reactions for a drug and event trends over time.
- 2026-10-18 `fda_food_recalls` removed
  - Search FDA FOOD recall / enforcement reports (openFDA /food/enforcement) — product recalls, reasons, classification, recalling firm, distribution, and status. Use for food-safety / recall-history questions (distinct from fda_drug_recalls which covers drugs).
- 2026-10-18 `fda_crl_detail` removed
  - Retrieve one FDA Complete Response Letter by application number and optionally letter date. Returns the FDA-disclosed letter text and document URL. Confidential commercial and trade-secret material may be redacted by FDA.
- 2026-10-18 `fda_complete_response_letters` removed
  - Search FDA-disclosed Complete Response Letters for drug and biologic applications. Defaults to letter_type "COMPLETE RESPONSE"; optionally include other letter types in the same dataset. Returns the application’s current approval_status, letter metadata, an excerpt, and the official document URL.

Full history: https://api.protogrid.dev/v1/servers/io.github.pipeworx-io%2Fopenfda/changes

## Remotes

- https://gateway.pipeworx.io/openfda/mcp (streamable-http, auth none, reachable true, uptime30d 0.982906)

## Packages

_none_

## Tools (0)

_none observed_