{
 "source": {
  "dataset": "openFDA Complete Response Letter transparency dataset",
  "url": "https://open.fda.gov/apis/transparency/completeresponseletters/",
  "api": "https://api.fda.gov/transparency/crl.json",
  "file": "openFDA-source-dataset-457-CRLs.json",
  "source_last_updated": "2026-07-22",
  "n_records": 457,
  "compiled_by": "Phase 3 Search"
 },
 "section_header": {
  "headline_pct": 62.6,
  "headline_n": 286,
  "denominator": 457,
  "groups": {
   "mfg_only": {
    "n": 202,
    "pct": 44.2
   },
   "both": {
    "n": 84,
    "pct": 18.4
   },
   "clinical_only": {
    "n": 58,
    "pct": 12.7
   },
   "neither": {
    "n": 113,
    "pct": 24.7
   }
  },
  "sensitivity": {
   "drop_uppercase_condition": {
    "n": 296,
    "pct": 64.8
   },
   "denominator_complete_response_only": {
    "n": 286,
    "denominator": 444,
    "pct": 64.4
   }
  },
  "claim": "share of published letters carrying an FDA manufacturing or quality deficiency SECTION HEADER; a presence signal, not a primary-cause coding"
 },
 "keyword_prevalence_directional": {
  "facility": {
   "n": 297,
   "pct": 65.0
  },
  "inspection": {
   "n": 273,
   "pct": 59.7
  },
  "stability": {
   "n": 112,
   "pct": 24.5
  },
  "sterility_aseptic": {
   "n": 38,
   "pct": 8.3
  },
  "impurity": {
   "n": 51,
   "pct": 11.2
  },
  "process_validation": {
   "n": 21,
   "pct": 4.6
  },
  "_both_mfg_and_clinical_language": {
   "n": 366,
   "pct": 80.1,
   "why_it_matters": "most letters discuss both, which is why keyword shares cannot be read as rejection causes"
  }
 },
 "by_year": {
  "2002": {
   "total_crls": 1,
   "approved_pct": 100.0,
   "manufacturing_quality_section_pct": 0.0
  },
  "2004": {
   "total_crls": 1,
   "approved_pct": 100.0,
   "manufacturing_quality_section_pct": 0.0
  },
  "2007": {
   "total_crls": 1,
   "approved_pct": 100.0,
   "manufacturing_quality_section_pct": 0.0
  },
  "2008": {
   "total_crls": 1,
   "approved_pct": 100.0,
   "manufacturing_quality_section_pct": 0.0
  },
  "2009": {
   "total_crls": 2,
   "approved_pct": 100.0,
   "manufacturing_quality_section_pct": 50.0
  },
  "2010": {
   "total_crls": 2,
   "approved_pct": 100.0,
   "manufacturing_quality_section_pct": 50.0
  },
  "2011": {
   "total_crls": 2,
   "approved_pct": 100.0,
   "manufacturing_quality_section_pct": 100.0
  },
  "2012": {
   "total_crls": 4,
   "approved_pct": 100.0,
   "manufacturing_quality_section_pct": 50.0
  },
  "2013": {
   "total_crls": 12,
   "approved_pct": 100.0,
   "manufacturing_quality_section_pct": 58.3
  },
  "2014": {
   "total_crls": 8,
   "approved_pct": 100.0,
   "manufacturing_quality_section_pct": 50.0
  },
  "2015": {
   "total_crls": 9,
   "approved_pct": 100.0,
   "manufacturing_quality_section_pct": 77.8
  },
  "2016": {
   "total_crls": 20,
   "approved_pct": 100.0,
   "manufacturing_quality_section_pct": 60.0
  },
  "2017": {
   "total_crls": 25,
   "approved_pct": 100.0,
   "manufacturing_quality_section_pct": 56.0
  },
  "2018": {
   "total_crls": 33,
   "approved_pct": 100.0,
   "manufacturing_quality_section_pct": 72.7
  },
  "2019": {
   "total_crls": 38,
   "approved_pct": 97.4,
   "manufacturing_quality_section_pct": 55.3
  },
  "2020": {
   "total_crls": 35,
   "approved_pct": 100.0,
   "manufacturing_quality_section_pct": 71.4
  },
  "2021": {
   "total_crls": 48,
   "approved_pct": 100.0,
   "manufacturing_quality_section_pct": 62.5
  },
  "2022": {
   "total_crls": 25,
   "approved_pct": 100.0,
   "manufacturing_quality_section_pct": 52.0
  },
  "2023": {
   "total_crls": 30,
   "approved_pct": 96.7,
   "manufacturing_quality_section_pct": 60.0
  },
  "2024": {
   "total_crls": 69,
   "approved_pct": 20.3,
   "manufacturing_quality_section_pct": 72.5
  },
  "2025": {
   "total_crls": 59,
   "approved_pct": 0.0,
   "manufacturing_quality_section_pct": 57.6
  },
  "2026": {
   "total_crls": 31,
   "approved_pct": 0.0,
   "manufacturing_quality_section_pct": 67.7
  },
  "no_letter_year": {
   "total_crls": 1,
   "approved_pct": 0.0,
   "manufacturing_quality_section_pct": 0.0
  }
 },
 "survivorship": {
  "approved_n": 309,
  "approved_pct": 67.6,
  "unapproved_n": 148,
  "unapproved_pct": 32.4,
  "warning": "NOT a recovery rate. The July 2025 tranche was selected from applications ultimately approved, so pre-2019 letter-years read ~100% approved by construction. Recovery rates must come from the peer-reviewed cohorts."
 },
 "letter_structure": {
  "typed_complete_response": 444,
  "other_action_types": {
   "TENTATIVE APPROVAL": 4,
   "PROVISIONAL DETERMINATION": 1,
   "REFUSAL TO FILE": 1,
   "CORRECTED PROVISIONAL DETERMINATION": 1,
   "NULL/none": 5,
   "RESCIND COMPLETE RESPONSE": 1
  },
  "pre_2008_not_approvable": 4,
  "records_without_text": [
   "Chiesi Farmaceutici S.p.A"
  ],
  "safety_update_boilerplate_header": 394
 },
 "application_type": {
  "small molecule (NDA)": {
   "n": 337,
   "pct": 73.7
  },
  "biologic (BLA)": {
   "n": 119,
   "pct": 26.0
  },
  "unspecified": {
   "n": 1,
   "pct": 0.2
  }
 },
 "application_type_vs_manufacturing": {
  "small molecule (NDA)": {
   "n": 337,
   "manufacturing_quality_section_pct": 60.5
  },
  "biologic (BLA)": {
   "n": 119,
   "manufacturing_quality_section_pct": 68.9
  }
 },
 "repeat_companies": {
  "companies_with_3_or_more": 31,
  "letters_they_account_for": 120,
  "share_of_archive_pct": 26.3,
  "top": [
   {
    "company": "Accord Healthcare Inc.",
    "crl_count": 6
   },
   {
    "company": "Sun Pharma Advanced Research Company Limited",
    "crl_count": 5
   },
   {
    "company": "Eli Lilly and Company",
    "crl_count": 5
   },
   {
    "company": "Regeneron Pharmaceuticals, Inc.",
    "crl_count": 5
   },
   {
    "company": "CELLTRION, Inc.",
    "crl_count": 5
   },
   {
    "company": "Hospira, Inc.",
    "crl_count": 5
   },
   {
    "company": "Fresenius Kabi USA, LLC",
    "crl_count": 5
   },
   {
    "company": "Tanvex BioPharma USA, Inc.",
    "crl_count": 5
   },
   {
    "company": "Mylan Laboratories Limited",
    "crl_count": 4
   },
   {
    "company": "Sun Pharmaceutical Industries Limited",
    "crl_count": 4
   },
   {
    "company": "HQ Specialty Pharma Corporation",
    "crl_count": 4
   },
   {
    "company": "Dr. Reddy\u2019s Laboratories Limited",
    "crl_count": 4
   },
   {
    "company": "Alvotech USA Inc.",
    "crl_count": 4
   },
   {
    "company": "Shilpa Medicare Limited",
    "crl_count": 4
   },
   {
    "company": "Kashiv BioSciences, LLC",
    "crl_count": 4
   },
   {
    "company": "CMP Development LLC",
    "crl_count": 4
   },
   {
    "company": "Ferring Pharmaceuticals Inc.",
    "crl_count": 4
   },
   {
    "company": "Accord BioPharma Inc.",
    "crl_count": 4
   },
   {
    "company": "Fera Pharmaceuticals, LLC",
    "crl_count": 3
   },
   {
    "company": "Azurity Pharmaceuticals, Inc.",
    "crl_count": 3
   }
  ]
 },
 "validation": {
  "baseline": "tier12/crl-data.csv",
  "checks_run": 75,
  "failures": [],
  "status": "PASS"
 }
}