483 Trending Citations

Discover the most frequently cited FDA 483 observations and emerging compliance trends.

Tier Access

Required Tier: Pro+ (Pro, Enterprise)

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

GET /v1/483/citations/trending

Get the most common FDA 483 citations with trend analysis, comparing the current FDA fiscal quarter against the previous quarter.

Request

GET https://api.ctwise.ai/v1/483/citations/trending?limit=20&product_type=drug
X-Api-Key: YOUR_API_KEY

Query Parameters

Parameter	Type	Required	Description
trend	string	No	Filter by trend direction: increasing, stable, decreasing
min_count	integer	No	Minimum occurrence count (default: 0)
product_type	string	No	Filter by product type (matches against top product types per CFR)
limit	integer	No	Maximum results to return (default: 20, max: 100)
offset	integer	No	Number of results to skip (default: 0)

Response

{
  "period": "FY2026-Q2",
  "previous_period": "FY2026-Q1",
  "results": [
    {
      "act_cfr_number": "21 CFR 211.160",
      "description": "Laboratory controls - general requirements",
      "occurrence_count": 487,
      "previous_count": 434,
      "trend_direction": "increasing",
      "percentage_change": 12.2,
      "top_product_types": ["Drug", "Biologic", "API"]
    },
    {
      "act_cfr_number": "21 CFR 211.192",
      "description": "Production record review",
      "occurrence_count": 423,
      "previous_count": 428,
      "trend_direction": "stable",
      "percentage_change": -1.2,
      "top_product_types": ["Drug", "Biologic"]
    },
    {
      "act_cfr_number": "21 CFR 211.22",
      "description": "Responsibilities of quality control unit",
      "occurrence_count": 398,
      "previous_count": 366,
      "trend_direction": "increasing",
      "percentage_change": 8.7,
      "top_product_types": ["Drug", "Medical Device"]
    }
  ],
  "total": 418,
  "offset": 0,
  "limit": 20,
  "total_citations_current": 269,
  "total_citations_previous": 1694,
  "filters_applied": {
    "trend": null,
    "min_count": 0,
    "product_type": null
  },
  "query_metadata": {
    "execution_time_ms": 150
  }
}

Response Fields

Field	Type	Description
period	string	Current FDA fiscal quarter (e.g., "FY2026-Q2")
previous_period	string	Previous FDA fiscal quarter for comparison
results	array	Array of trending citations
results[].act_cfr_number	string	CFR citation (e.g., "21 CFR 211.160")
results[].description	string	Brief description of the CFR requirement
results[].occurrence_count	integer	Number of times cited in current period
results[].previous_count	integer	Number of times cited in previous period
results[].trend_direction	string	increasing, stable, or decreasing
results[].percentage_change	number	Percentage change vs previous period
results[].top_product_types	string[]	Product types most associated with this citation
total	integer	Total CFRs analyzed
offset	integer	Current offset
limit	integer	Page size
total_citations_current	integer	Total citations in current period
total_citations_previous	integer	Total citations in previous period
filters_applied	object	Applied filters
query_metadata	object	Execution metadata

Examples

Get All Trending Citations

curl -X GET "https://api.ctwise.ai/v1/483/citations/trending?limit=10" \
  -H "X-Api-Key: YOUR_API_KEY"

Filter by Trend Direction

curl -X GET "https://api.ctwise.ai/v1/483/citations/trending?trend=increasing&limit=20" \
  -H "X-Api-Key: YOUR_API_KEY"

Filter by Product Type

curl -X GET "https://api.ctwise.ai/v1/483/citations/trending?product_type=drug&limit=20" \
  -H "X-Api-Key: YOUR_API_KEY"

High-Frequency Citations Only

curl -X GET "https://api.ctwise.ai/v1/483/citations/trending?min_count=100&limit=10" \
  -H "X-Api-Key: YOUR_API_KEY"

Python Example

import requests

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

response = requests.get(
    f"{BASE_URL}/483/citations/trending",
    headers={"X-Api-Key": API_KEY},
    params={
        "limit": 20
    }
)

data = response.json()

print(f"Trending Citations - {data['period']} vs {data['previous_period']}")
print(f"Total CFRs analyzed: {data['total']}\n")
print("Top 10 Citations:")
print("-" * 80)

for i, citation in enumerate(data['results'][:10], 1):
    trend = "+" if citation['trend_direction'] == "increasing" else "-" if citation['trend_direction'] == "decreasing" else "="

    print(f"{i}. {citation['act_cfr_number']}: {citation['description']}")
    print(f"   Count: {citation['occurrence_count']} ({trend}{abs(citation['percentage_change']):.1f}%)")
    print(f"   Trend: {citation['trend_direction']}")
    if citation.get('top_product_types'):
        print(f"   Products: {', '.join(citation['top_product_types'])}")
    print()

Python Example - Identify Emerging Trends

import requests

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

# Get only increasing citations
response = requests.get(
    f"{BASE_URL}/483/citations/trending",
    headers={"X-Api-Key": API_KEY},
    params={
        "trend": "increasing",
        "min_count": 10,
        "limit": 50
    }
)

data = response.json()

print("Emerging Compliance Trends (Increasing Citations):")
print("-" * 80)

for citation in data['results']:
    print(f"{citation['act_cfr_number']}: {citation['description']}")
    print(f"  Current: {citation['occurrence_count']} | Previous: {citation['previous_count']}")
    print(f"  Change: +{citation['percentage_change']:.1f}%")
    print()

JavaScript Example

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

const response = await fetch(
  `${BASE_URL}/483/citations/trending?limit=15`,
  {
    headers: { 'X-Api-Key': API_KEY }
  }
);

const data = await response.json();

console.log(`Trending Citations (${data.period} vs ${data.previous_period})`);
console.log(`Total CFRs: ${data.total}\n`);

// Find high-risk increasing trends
const emerging = data.results.filter(
  c => c.trend_direction === 'increasing' && c.percentage_change > 10
);

console.log('Rapidly Increasing Citations (>10%):');
emerging.forEach(citation => {
  console.log(`${citation.act_cfr_number}: ${citation.description}`);
  console.log(`  ${citation.occurrence_count} citations (+${citation.percentage_change.toFixed(1)}%)`);
  if (citation.top_product_types) {
    console.log(`  Products: ${citation.top_product_types.join(', ')}`);
  }
  console.log();
});

Error Responses

Invalid API Key

{
  "message": "Unauthorized"
}

Status: 401 Unauthorized

Performance

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

Interpretation Notes

• period / previous_period: Uses FDA fiscal quarters (e.g., "FY2026-Q2"). FDA fiscal year starts October 1st.
• trend_direction: Based on percentage change between current and previous period. increasing = positive change, decreasing = negative change, stable = minimal change.
• percentage_change: Positive values indicate increasing citations (emerging issue), negative values indicate declining citations.
• top_product_types: Product categories most associated with this CFR citation based on facility inspection data.

Use Cases

1. Compliance Prioritization - Focus remediation efforts on most frequently cited areas
2. Trend Analysis - Identify emerging compliance issues before they become systemic
3. Benchmarking - Compare your citation profile against industry trends
4. Training - Develop targeted training programs based on common deficiencies
5. Regulatory Intelligence - Understand FDA enforcement priorities by quarter

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Related Endpoints

• POST /v1/483/observations/search - Search for specific observations
• GET /v1/483/analytics/summary - Analytics summary
• GET /v1/483/cfr-references - CFR reference details