483 Facility Endpoints

Retrieve facility inspection history and risk scores for FDA-regulated establishments.

Tier Access

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

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

GET /v1/483/facilities/{fei_number}/inspections

Get complete inspection history and compliance track record for a specific facility.

Request

GET https://api.ctwise.ai/v1/483/facilities/3005012345/inspections?classification=OAI&include_citations=true
X-Api-Key: YOUR_API_KEY

Path Parameters

Parameter	Type	Required	Description
fei_number	string	Yes	FDA Establishment Identifier (FEI)

Query Parameters

Parameter	Type	Required	Description
classification	string	No	Filter by classification: NAI, VAI, or OAI
date_from	string	No	Start date for inspection range (ISO 8601)
date_to	string	No	End date for inspection range (ISO 8601)
include_citations	boolean	No	Include detailed observation citations (default: false)
include_compliance_actions	boolean	No	Include warning letters, recalls, etc. (default: false)

Response

{
  "fei_number": "3005012345",
  "facility": {
    "legal_name": "Acme Pharmaceutical Manufacturing",
    "city": "Boston",
    "state": "MA",
    "country": "USA",
    "product_types": ["drug", "biologics"],
    "parent_company": "Acme Holdings Inc.",
    "registration_status": "active",
    "establishment_type": "manufacturer"
  },
  "summary": {
    "total_inspections": 12,
    "nai_count": 5,
    "vai_count": 4,
    "oai_count": 3,
    "warning_letters": 1,
    "import_alerts": 0,
    "last_inspection_date": "2024-03-15",
    "last_classification": "OAI",
    "trend": "deteriorating"
  },
  "inspections": [
    {
      "inspection_id": "483-2024-001234",
      "inspection_start_date": "2024-03-11",
      "inspection_end_date": "2024-03-15",
      "classification": "OAI",
      "program_area": "CDER",
      "inspection_type": "Pre-Approval Inspection",
      "lead_investigator_id": "INV-00456",
      "team_size": 3,
      "total_citations": 8,
      "citations": [
        {
          "observation_id": "483-2024-001234-obs-003",
          "act_cfr_number": "21 CFR 211.113",
          "short_description": "Sterile manufacturing area lacks adequate environmental monitoring",
          "categories": [
            "Aseptic Processing",
            "Environmental Monitoring",
            "Sterility Assurance"
          ],
          "severity_score": 8.5
        },
        {
          "observation_id": "483-2024-001234-obs-001",
          "act_cfr_number": "21 CFR 211.160",
          "short_description": "Laboratory controls inadequate for stability testing",
          "categories": [
            "Laboratory Controls",
            "Stability Studies"
          ],
          "severity_score": 7.2
        }
      ],
      "compliance_actions": [
        {
          "action_type": "warning_letter",
          "action_date": "2024-05-10",
          "action_id": "WL-2024-456",
          "status": "pending_response",
          "response_deadline": "2024-06-09"
        }
      ]
    },
    {
      "inspection_id": "483-2022-009876",
      "inspection_start_date": "2022-08-15",
      "inspection_end_date": "2022-08-19",
      "classification": "VAI",
      "program_area": "CDER",
      "inspection_type": "Routine Surveillance",
      "lead_investigator_id": "INV-00789",
      "team_size": 2,
      "total_citations": 3,
      "citations": [
        {
          "observation_id": "483-2022-009876-obs-001",
          "act_cfr_number": "21 CFR 211.192",
          "short_description": "Production record review procedures need improvement",
          "categories": [
            "Documentation",
            "Quality Systems"
          ],
          "severity_score": 5.8
        }
      ],
      "compliance_actions": []
    }
  ]
}

Response Fields

Field	Type	Description
fei_number	string	FDA Establishment Identifier
facility	object	Facility information
facility.legal_name	string	Registered legal name
facility.city	string	City location
facility.state	string	State/province
facility.country	string	Country
facility.product_types	string[]	Types of products manufactured
facility.parent_company	string	Parent company name
summary	object	Inspection summary statistics
summary.total_inspections	integer	Total number of inspections
summary.nai_count	integer	No Action Indicated count
summary.vai_count	integer	Voluntary Action Indicated count
summary.oai_count	integer	Official Action Indicated count
summary.warning_letters	integer	Warning letters issued
summary.trend	string	Compliance trend (improving/stable/deteriorating)
inspections	array	Array of inspection records
inspections[].inspection_id	string	Unique inspection identifier
inspections[].classification	string	Inspection classification
inspections[].citations	array	Observation citations (if requested)
inspections[].compliance_actions	array	Regulatory actions (if requested)

---

GET /v1/483/facilities/{fei_number}/citations

Get all FDA 483 observation citations for a specific facility, sorted by inspection date.

Request

GET https://api.ctwise.ai/v1/483/facilities/3005012345/citations?limit=20&sort_order=desc
X-Api-Key: YOUR_API_KEY

Path Parameters

Parameter	Type	Required	Description
fei_number	string	Yes	FDA Establishment Identifier (FEI)

Query Parameters

Parameter	Type	Required	Description
limit	integer	No	Maximum number of citations to return (default: 100, max: 1000)
sort_order	string	No	Sort order: asc or desc (default: desc)
category	string	No	Filter by citation category
date_from	string	No	Start date for inspection range (ISO 8601)
date_to	string	No	End date for inspection range (ISO 8601)

Response

{
  "fei_number": "3005012345",
  "facility_name": "Acme Pharmaceutical Manufacturing",
  "total": 45,
  "results": [
    {
      "citation_id": "CIT-2024-12345",
      "inspection_id": "INS-2024-67890",
      "inspection_end_date": "2024-03-15",
      "fiscal_year": 2024,
      "act_cfr_number": "21 CFR 211.113",
      "short_description": "Sterile manufacturing area lacks adequate environmental monitoring procedures as required",
      "program_area": "Human Drugs",
      "classification": "OAI",
      "category": "Sterility Assurance",
      "source": "FDA Inspection Database",
      "source_url": "https://datadashboard.fda.gov/ora/cd/inspections.htm",
      "data_attribution": {
        "api_version": "v1.0",
        "data_source_name": "FDA ORA Inspection Database",
        "data_source_url": "https://datadashboard.fda.gov/ora/cd/inspections.htm",
        "last_updated": "2024-09-15T00:00:00Z"
      }
    },
    {
      "citation_id": "CIT-2024-12346",
      "inspection_id": "INS-2024-67890",
      "inspection_end_date": "2024-03-15",
      "fiscal_year": 2024,
      "act_cfr_number": "21 CFR 211.160",
      "short_description": "Laboratory controls inadequate for stability testing program",
      "program_area": "Human Drugs",
      "classification": "OAI",
      "category": "Laboratory Controls",
      "source": "FDA Inspection Database",
      "source_url": "https://datadashboard.fda.gov/ora/cd/inspections.htm",
      "data_attribution": {
        "api_version": "v1.0",
        "data_source_name": "FDA ORA Inspection Database",
        "data_source_url": "https://datadashboard.fda.gov/ora/cd/inspections.htm",
        "last_updated": "2024-09-15T00:00:00Z"
      }
    }
  ],
  "query_metadata": {
    "execution_time_ms": 120,
    "limit": 20,
    "sort_order": "desc"
  }
}

Response Fields

Field	Type	Description
fei_number	string	FDA Establishment Identifier
facility_name	string	Facility legal name
total	integer	Total number of citations for this facility
results	array	Array of citation records
results[].citation_id	string	Unique citation identifier
results[].inspection_id	string	Inspection identifier
results[].inspection_end_date	string	Date inspection ended (ISO 8601)
results[].fiscal_year	integer	FDA fiscal year
results[].act_cfr_number	string	CFR section cited (21 CFR format)
results[].short_description	string	Citation description
results[].program_area	string	FDA program area (Human Drugs, Biologics, etc.)
results[].classification	string	Inspection classification (NAI, VAI, OAI)
results[].category	string	NLP-classified citation category
results[].source	string	Data source name
results[].source_url	string	Link to FDA data source
results[].data_attribution	object	Data attribution metadata
results[].data_attribution.api_version	string	API version
results[].data_attribution.data_source_name	string	Source database name
results[].data_attribution.data_source_url	string	Source URL
results[].data_attribution.last_updated	string	Last data refresh date
query_metadata	object	Query execution metadata

Examples

Get All Citations for a Facility

curl -X GET "https://api.ctwise.ai/v1/483/facilities/3005012345/citations?limit=50" \
  -H "X-Api-Key: YOUR_API_KEY"

Filter by Category

curl -X GET "https://api.ctwise.ai/v1/483/facilities/3005012345/citations?category=Data%20Integrity&limit=20" \
  -H "X-Api-Key: YOUR_API_KEY"

Get Citations for Date Range

curl -X GET "https://api.ctwise.ai/v1/483/facilities/3005012345/citations?date_from=2023-01-01&date_to=2024-12-31" \
  -H "X-Api-Key: YOUR_API_KEY"

Python Example

import requests

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

# Get all citations for a facility
fei_number = "3005012345"
response = requests.get(
    f"{BASE_URL}/483/facilities/{fei_number}/citations",
    headers={"X-Api-Key": API_KEY},
    params={"limit": 50, "sort_order": "desc"}
)

data = response.json()
print(f"{data['facility_name']}: {data['total']} total citations\n")

for citation in data["results"]:
    print(f"Date: {citation['inspection_end_date']}")
    print(f"CFR: {citation['act_cfr_number']}")
    print(f"Category: {citation['category']}")
    print(f"Description: {citation['short_description'][:80]}...")
    print()

JavaScript Example

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

const feiNumber = '3005012345';
const response = await fetch(
  `${BASE_URL}/483/facilities/${feiNumber}/citations?limit=50&sort_order=desc`,
  { headers: { 'X-Api-Key': API_KEY } }
);

const data = await response.json();
console.log(`${data.facility_name}: ${data.total} total citations`);

data.results.forEach(citation => {
  console.log(`${citation.inspection_end_date}: ${citation.act_cfr_number}`);
  console.log(`  ${citation.short_description.substring(0, 80)}...`);
});

Error Responses

Facility Not Found

{
  "error": {
    "code": "NOT_FOUND",
    "message": "Facility with FEI number '3005012345' not found"
  }
}

Status: 404 Not Found

---

GET /v1/483/facilities/{fei_number}/score

Get AI-powered predictive risk score and recommended actions for a facility.

Request

GET https://api.ctwise.ai/v1/483/facilities/3005012345/score
X-Api-Key: YOUR_API_KEY

Path Parameters

Parameter	Type	Required	Description
fei_number	string	Yes	FDA Establishment Identifier (FEI)

Response

{
  "fei_number": "3005012345",
  "facility_name": "Acme Pharmaceutical Manufacturing",
  "risk_score": 78,
  "risk_level": "high",
  "confidence": 0.87,
  "score_components": {
    "historical_pattern": {
      "score": 82,
      "weight": 0.35,
      "factors": [
        "3 OAI inspections in last 5 years",
        "1 warning letter in last 24 months",
        "Deteriorating trend in classification"
      ]
    },
    "time_since_inspection": {
      "score": 65,
      "weight": 0.15,
      "factors": [
        "Last inspection: 11 months ago",
        "Average inspection interval: 18 months",
        "Due for routine inspection in ~7 months"
      ]
    },
    "citation_severity": {
      "score": 85,
      "weight": 0.25,
      "factors": [
        "Average severity score: 7.8/10",
        "Repeat citations in aseptic processing",
        "Critical CFR violations (211.113, 211.160)"
      ]
    },
    "industry_benchmark": {
      "score": 70,
      "weight": 0.15,
      "factors": [
        "OAI rate: 25% vs industry avg 12%",
        "Citations per inspection: 6.7 vs avg 3.2",
        "Warning letter rate: 8% vs avg 3%"
      ]
    },
    "enforcement_trend": {
      "score": 75,
      "weight": 0.10,
      "factors": [
        "Pending warning letter response",
        "No import alerts currently active",
        "No consent decrees"
      ]
    }
  },
  "next_best_actions": [
    {
      "priority": 1,
      "action": "Conduct comprehensive gap assessment against 21 CFR 211.113 (aseptic processing)",
      "rationale": "Repeat citations in this area with high severity scores indicate systemic deficiency",
      "estimated_remediation_days": 90
    },
    {
      "priority": 2,
      "action": "Engage external consultant for environmental monitoring program review",
      "rationale": "Critical observation in latest inspection; external expertise recommended",
      "estimated_remediation_days": 60
    },
    {
      "priority": 3,
      "action": "Prepare for likely follow-up inspection within 6-9 months",
      "rationale": "OAI classification and pending warning letter response typically trigger follow-up",
      "estimated_remediation_days": 180
    },
    {
      "priority": 4,
      "action": "Implement trending dashboard for environmental monitoring excursions",
      "rationale": "Proactive monitoring can prevent future citations in this high-risk area",
      "estimated_remediation_days": 45
    }
  ],
  "calculated_at": "2025-02-14T10:30:00Z",
  "valid_until": "2025-03-14T10:30:00Z"
}

Response Fields

Field	Type	Description
fei_number	string	FDA Establishment Identifier
facility_name	string	Facility name
risk_score	integer	Overall risk score (0-100, higher = more risk)
risk_level	string	Risk level: low (0-40), medium (41-65), high (66-85), critical (86-100)
confidence	number	Model confidence (0.0-1.0)
score_components	object	Detailed scoring breakdown
score_components.*.score	integer	Component score (0-100)
score_components.*.weight	number	Component weight in overall score
score_components.*.factors	string[]	Contributing factors
next_best_actions	array	Recommended actions prioritized by impact
next_best_actions[].priority	integer	Priority ranking
next_best_actions[].action	string	Recommended action
next_best_actions[].rationale	string	Why this action is recommended
next_best_actions[].estimated_remediation_days	integer	Estimated days to complete
calculated_at	string	Timestamp when score was calculated
valid_until	string	Score expiration (refreshed monthly)

Examples

Get Facility Inspection History

curl -X GET "https://api.ctwise.ai/v1/483/facilities/3005012345/inspections?include_citations=true&include_compliance_actions=true" \
  -H "X-Api-Key: YOUR_API_KEY"

Get OAI Inspections Only

curl -X GET "https://api.ctwise.ai/v1/483/facilities/3005012345/inspections?classification=OAI&date_from=2020-01-01" \
  -H "X-Api-Key: YOUR_API_KEY"

Get Facility Risk Score

curl -X GET "https://api.ctwise.ai/v1/483/facilities/3005012345/score" \
  -H "X-Api-Key: YOUR_API_KEY"

Python Example - Inspection History

import requests

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

# Get inspection history
response = requests.get(
    f"{BASE_URL}/483/facilities/3005012345/inspections",
    headers={"X-Api-Key": API_KEY},
    params={
        "include_citations": True,
        "include_compliance_actions": True
    }
)

data = response.json()
facility = data['facility']
summary = data['summary']

print(f"{facility['legal_name']} ({facility['city']}, {facility['state']})")
print(f"Total Inspections: {summary['total_inspections']}")
print(f"OAI Rate: {summary['oai_count'] / summary['total_inspections'] * 100:.1f}%")
print(f"Trend: {summary['trend']}")
print("\nRecent Inspections:")

for inspection in data['inspections'][:5]:
    print(f"  {inspection['inspection_end_date']}: {inspection['classification']} - {inspection['total_citations']} citations")
    if 'compliance_actions' in inspection and inspection['compliance_actions']:
        for action in inspection['compliance_actions']:
            print(f"    → {action['action_type']}: {action['action_id']}")

Python Example - Risk Score

import requests

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

# Get risk score
response = requests.get(
    f"{BASE_URL}/483/facilities/3005012345/score",
    headers={"X-Api-Key": API_KEY}
)

data = response.json()

print(f"Facility: {data['facility_name']}")
print(f"Risk Score: {data['risk_score']}/100 ({data['risk_level'].upper()})")
print(f"Confidence: {data['confidence']:.0%}")
print("\nTop Recommended Actions:")

for action in data['next_best_actions'][:3]:
    print(f"{action['priority']}. {action['action']}")
    print(f"   Why: {action['rationale']}")
    print(f"   Timeline: ~{action['estimated_remediation_days']} days\n")

JavaScript Example

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

// Get inspection history
const historyResponse = await fetch(
  `${BASE_URL}/483/facilities/3005012345/inspections?include_citations=true`,
  {
    headers: { 'X-Api-Key': API_KEY }
  }
);

const history = await historyResponse.json();
console.log(`${history.facility.legal_name}: ${history.summary.total_inspections} inspections`);

// Get risk score
const scoreResponse = await fetch(
  `${BASE_URL}/483/facilities/3005012345/score`,
  {
    headers: { 'X-Api-Key': API_KEY }
  }
);

const score = await scoreResponse.json();
console.log(`Risk Level: ${score.risk_level} (${score.risk_score}/100)`);
console.log('Top Action:', score.next_best_actions[0].action);

Error Responses

Facility Not Found

{
  "error": {
    "code": "NOT_FOUND",
    "message": "Facility with FEI number '3005012345' not found"
  }
}

Status: 404 Not Found

Invalid FEI Format

{
  "error": {
    "code": "VALIDATION_ERROR",
    "message": "Invalid FEI number format. Expected 10-digit number."
  }
}

Status: 400 Bad Request

Invalid API Key

{
  "message": "Unauthorized"
}

Status: 401 Unauthorized

Performance

Metric	Target
Response time	< 2 seconds
Data freshness	Updated weekly
Timeout	30 seconds

Notes on Risk Scoring

• Risk scores are recalculated monthly using the latest inspection data
• Scores incorporate both historical patterns and forward-looking indicators
• Component weights are calibrated using FDA enforcement patterns
• High/critical scores do not guarantee regulatory action, but indicate elevated risk
• Use scores as one input in overall compliance strategy, not sole decision factor

---

Related Endpoints

• POST /v1/483/observations/search - Search observations
• POST /v1/483/watchlist - Monitor facilities
• GET /v1/483/analytics/benchmarks - Industry benchmarking