483 Investigator Intelligence

Access FDA investigator profiles and inspection patterns based on public records.

Tier Access

Required Tier: Starter+ (Starter, Pro, Enterprise)

Rate limits apply per tier — see Rate Limits for details.

GET /v1/483/investigators

List investigator profiles with filtering, sorting, and pagination.

Request

GET https://api.ctwise.ai/v1/483/investigators?min_inspections=10&sort_by=total_inspections&limit=20
X-Api-Key: YOUR_API_KEY

Query Parameters

Parameter	Type	Required	Description
min_inspections	integer	No	Minimum number of inspections (default: 0)
product_type	string	No	Filter by product type (matches against investigator's top product types)
sort_by	string	No	Sort by: total_inspections, oai_rate, facilities_inspected, name (default: total_inspections)
limit	integer	No	Maximum results to return (default: 20, max: 100)
offset	integer	No	Number of results to skip (default: 0)

Response

{
  "results": [
    {
      "investigator_name": "J. Smith",
      "total_inspections": 147,
      "oai_rate": 0.231,
      "facilities_inspected": 89,
      "top_product_types": ["Sterile Injectables", "Oral Solids", "APIs"],
      "top_cfrs": [
        {"cfr": "21 CFR 211.160", "count": 42},
        {"cfr": "21 CFR 211.192", "count": 38},
        {"cfr": "21 CFR 211.100", "count": 31}
      ]
    },
    {
      "investigator_name": "A. Johnson",
      "total_inspections": 98,
      "oai_rate": 0.204,
      "facilities_inspected": 64,
      "top_product_types": ["Biologics", "Sterile Injectables"],
      "top_cfrs": [
        {"cfr": "21 CFR 211.22", "count": 28},
        {"cfr": "21 CFR 211.113", "count": 25}
      ]
    }
  ],
  "total": 2,
  "offset": 0,
  "limit": 20,
  "filters_applied": {
    "min_inspections": 10,
    "product_type": null,
    "sort_by": "total_inspections"
  },
  "query_metadata": {
    "execution_time_ms": 120
  }
}

Response Fields

Field	Type	Description
results	array	Array of investigator profiles
results[].investigator_name	string	Investigator name from public FDA records
results[].total_inspections	integer	Total inspections in CTWise database
results[].oai_rate	number	OAI classification rate (0.0-1.0)
results[].facilities_inspected	integer	Number of unique facilities inspected
results[].top_product_types	string[]	Most common product types inspected
results[].top_cfrs	array	Most frequently cited CFR references
results[].top_cfrs[].cfr	string	CFR reference (e.g., "21 CFR 211.160")
results[].top_cfrs[].count	integer	Number of times cited
total	integer	Total results matching filters
offset	integer	Current offset
limit	integer	Page size
filters_applied	object	Applied search filters
query_metadata	object	Execution metadata

---

GET /v1/483/investigators/{name}

Get detailed profile for a specific FDA investigator by name. Case-insensitive lookup.

Request

GET https://api.ctwise.ai/v1/483/investigators/J.%20Smith
X-Api-Key: YOUR_API_KEY

Path Parameters

Parameter	Type	Required	Description
name	string	Yes	Investigator name (URL-encoded, case-insensitive)

Response

{
  "investigator_name": "J. Smith",
  "total_inspections": 147,
  "oai_rate": 0.231,
  "facilities_inspected": 89,
  "top_product_types": ["Sterile Injectables", "Oral Solids", "APIs"],
  "top_cfrs": [
    {"cfr": "21 CFR 211.160", "count": 42},
    {"cfr": "21 CFR 211.192", "count": 38},
    {"cfr": "21 CFR 211.100", "count": 31}
  ],
  "query_metadata": {
    "execution_time_ms": 85
  }
}

---

Examples

List Investigators

curl -X GET "https://api.ctwise.ai/v1/483/investigators?min_inspections=20&sort_by=oai_rate&limit=10" \
  -H "X-Api-Key: YOUR_API_KEY"

Get Investigator by Name

curl -X GET "https://api.ctwise.ai/v1/483/investigators/J.%20Smith" \
  -H "X-Api-Key: YOUR_API_KEY"

Filter by Product Type

curl -X GET "https://api.ctwise.ai/v1/483/investigators?product_type=sterile+injectables&min_inspections=10" \
  -H "X-Api-Key: YOUR_API_KEY"

Python Example - Investigator Profile

import requests

API_KEY = "your_api_key"
BASE_URL = "https://api.ctwise.ai/v1"

# List investigators with high OAI rates
response = requests.get(
    f"{BASE_URL}/483/investigators",
    headers={"X-Api-Key": API_KEY},
    params={
        "min_inspections": 20,
        "sort_by": "oai_rate",
        "limit": 10
    }
)

data = response.json()
print(f"Found {data['total']} investigators with 20+ inspections\n")

for inv in data['results']:
    print(f"{inv['investigator_name']}")
    print(f"  Inspections: {inv['total_inspections']}")
    print(f"  OAI Rate: {inv['oai_rate']:.1%}")
    print(f"  Facilities: {inv['facilities_inspected']}")
    if inv.get('top_cfrs'):
        print(f"  Top Citation: {inv['top_cfrs'][0]['cfr']} ({inv['top_cfrs'][0]['count']}x)")
    print()

Python Example - Inspection Preparation

import requests

API_KEY = "your_api_key"
BASE_URL = "https://api.ctwise.ai/v1"

# Find investigators for your product type
response = requests.get(
    f"{BASE_URL}/483/investigators",
    headers={"X-Api-Key": API_KEY},
    params={
        "product_type": "sterile injectables",
        "min_inspections": 30,
        "sort_by": "total_inspections",
        "limit": 10
    }
)

investigators = response.json()['results']

print("FDA Investigators - Sterile Injectables")
print("=" * 60)

for inv in investigators:
    print(f"\n{inv['investigator_name']}")
    print(f"  Inspections: {inv['total_inspections']} | OAI Rate: {inv['oai_rate']:.1%}")

    if inv.get('top_cfrs'):
        print("  Top CFR Citations:")
        for cfr in inv['top_cfrs'][:3]:
            print(f"    {cfr['cfr']} ({cfr['count']}x)")

    if inv.get('top_product_types'):
        print(f"  Product Types: {', '.join(inv['top_product_types'])}")

print("\n" + "=" * 60)
print("Preparation Tips:")
print("  1. Review top citation areas for investigators in your product type")
print("  2. Conduct self-inspection focused on common deficiency categories")
print("  3. Prepare documentation for high-frequency CFR citations")

JavaScript Example

const API_KEY = 'your_api_key';
const BASE_URL = 'https://api.ctwise.ai/v1';

// Get investigators sorted by OAI rate
const response = await fetch(
  `${BASE_URL}/483/investigators?min_inspections=20&sort_by=oai_rate&limit=10`,
  {
    headers: { 'X-Api-Key': API_KEY }
  }
);

const data = await response.json();

console.log(`${data.total} Investigators (20+ inspections)\n`);

data.results.forEach((inv, idx) => {
  console.log(`${idx + 1}. ${inv.investigator_name}`);
  console.log(`   OAI Rate: ${(inv.oai_rate * 100).toFixed(1)}%`);
  console.log(`   Inspections: ${inv.total_inspections}`);
  if (inv.top_product_types) {
    console.log(`   Products: ${inv.top_product_types.join(', ')}`);
  }
});

Error Responses

Investigator Not Found

{
  "error": "Investigator 'John Doe' not found",
  "status_code": 404
}

Status: 404 Not Found

Invalid API Key

{
  "message": "Unauthorized"
}

Status: 401 Unauthorized

Performance

Metric	Target
List response time	< 2 seconds
Detail response time	< 2 seconds
Data freshness	Updated weekly (via intelligence pipeline)
Caching	5-minute Lambda-level cache
Timeout	30 seconds

Important Disclaimers

1. Public Records Only: All investigator data is compiled from publicly available FDA 483 forms and establishment inspection reports. No confidential FDA information is used.

2. Informational Purpose: This data is intended for informational and research purposes only. It does not represent:

   • Official FDA investigator assignments
   • Investigator qualifications or certifications
   • FDA inspection scheduling or planning
   • Individual investigator performance evaluations

3. Privacy: Investigator names may be abbreviated as they appear in public FDA records.

4. No Prediction: Past inspection patterns do not guarantee future inspector assignment or inspection outcomes.

5. Ethical Use: This data should be used to improve compliance programs, not to target or profile individual investigators.

6. Data Limitations:

   • Based only on inspections resulting in FDA 483s
   • Limited to data available in public FDA databases
   • Investigator profiling depends on name fields being populated in source data

Recommended Use Cases

Appropriate Uses:

• Understand common citation categories for inspection preparation
• Benchmark your facility's citation profile against industry patterns
• Tailor inspection readiness training to likely focus areas
• Analyze compliance trends by product type

Inappropriate Uses:

• Attempting to influence inspector assignment
• Profiling individual investigators for adversarial purposes
• Making assumptions about future inspection outcomes

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Related Endpoints

• POST /v1/483/observations/search - Search observations
• GET /v1/483/citations/trending - Trending citations
• GET /v1/483/facilities - Facility inspection history