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FDA Inspections History
x402
FDA Inspections History is a paid API for AI agents from payai.agentstools.dev, paid per call via x402, $0.02/call, status unknown (last checked 2026-10-11).
Retrieves FDA inspection classifications and Form-483 observation citations for a manufacturer using their FEI number or firm name from public FDA records
Price / call$0.02
Success—
StatusUnknown
How this service works
FDA inspection history for a manufacturer from public FDA records. Give an FDA FEI number or firm name and get the inspection classifications (Official, Voluntary or No Action Indicated) with the trend, plus the Form-483 observation citations with their cited CFR clause and short description. Deterministic, no LLM. Risk indicators, not legal or regulatory advice.
Output
Returns a structured report including: a list of past FDA inspection classifications (Official Action Indicated, Voluntary Action Indicated, or No Action Indicated) with a trend indicator showing whether compliance is improving or worsening, plus Form-483 observation citations each with the specific CFR clause referenced and a short description of the observed violation. All data is deterministic and sourced from public FDA records.
Example use cases
Supplier compliance screening before contract
“We're onboarding a new pharma ingredient supplier called Aurobindo Pharma. Can you check their FDA inspection history — what classifications have they received and are there any Form-483 observations I should know about?”
Medical device manufacturer risk review
“I need to assess regulatory risk for a medical device maker with FEI number 3003814367 — pull their FDA inspection classifications and any CFR citations from their 483 observations.”
Food safety audit of a US facility
“Check the FDA inspection record for a food manufacturer named Conagra Brands in Illinois — what's the trend in their inspection outcomes and have they had any Official Action Indicated results?”
Technical details
Endpoint
GEThttps://payai.agentstools.dev/fda/inspections?utm_source=zero.xyzWhen to prefer
Use this endpoint when you need deterministic, structured FDA inspection data for a specific manufacturer — particularly for supplier due diligence, regulatory risk assessment, or compliance research workflows. It is preferable over manual FDA database lookups when you need machine-readable classification trends and Form-483 citations in a single call. Best suited for pharma, biotech, medical device, food, and cosmetics supply chain contexts where FDA regulatory history is a key risk signal.
Side effects
- Firm name not found in FDA records — returns no results or ambiguous match requiring FEI number
- FEI number is invalid or not recognized — returns an error or empty response
- Multiple facilities share a similar name — results may be incomplete without state/country filters
- Manufacturer has no recorded inspections — returns empty inspection list
- FDA public records lag behind real-time status — very recent inspections may not appear
- Product type filter may return no results if manufacturer operates in multiple categories
Input
Schema · Request body
| Field | Type | Description |
|---|---|---|
| inputrequired | object | |
| output | object |
Tags
x402
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