{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-08"
  },
  "results": [
    {
      "term": "Process control",
      "count": 764
    },
    {
      "term": "Other",
      "count": 616
    },
    {
      "term": "Nonconforming Material/Component",
      "count": 487
    },
    {
      "term": "Under Investigation by firm",
      "count": 477
    },
    {
      "term": "Device Design",
      "count": 409
    },
    {
      "term": "Component design/selection",
      "count": 280
    },
    {
      "term": "Packaging process control",
      "count": 153
    },
    {
      "term": "Employee error",
      "count": 102
    },
    {
      "term": "Labeling design",
      "count": 88
    },
    {
      "term": "Package design/selection",
      "count": 74
    },
    {
      "term": "Process design",
      "count": 74
    },
    {
      "term": "Error in labeling",
      "count": 67
    },
    {
      "term": "Packaging",
      "count": 58
    },
    {
      "term": "Process change control",
      "count": 58
    },
    {
      "term": "Labeling Change Control",
      "count": 55
    },
    {
      "term": "Labeling mix-ups",
      "count": 54
    },
    {
      "term": "Mixed-up of materials/components",
      "count": 43
    },
    {
      "term": "Labeling False and Misleading",
      "count": 42
    },
    {
      "term": "Unknown/Undetermined by firm",
      "count": 30
    },
    {
      "term": "Material/Component Contamination",
      "count": 28
    },
    {
      "term": "Storage",
      "count": 25
    },
    {
      "term": "Component change control",
      "count": 21
    },
    {
      "term": "No Marketing Application",
      "count": 20
    },
    {
      "term": "Equipment maintenance",
      "count": 17
    },
    {
      "term": "Release of Material/Component prior to receiving test results",
      "count": 15
    },
    {
      "term": "Incorrect or no expiration date",
      "count": 14
    },
    {
      "term": "Software design",
      "count": 13
    },
    {
      "term": "Use error",
      "count": 13
    },
    {
      "term": "Packaging change control",
      "count": 10
    },
    {
      "term": "Software change control",
      "count": 9
    },
    {
      "term": "Environmental control",
      "count": 8
    },
    {
      "term": "Pending",
      "count": 8
    },
    {
      "term": "Vendor change control",
      "count": 7
    },
    {
      "term": "Manufacturing material removal",
      "count": 4
    },
    {
      "term": "Reprocessing Controls",
      "count": 3
    },
    {
      "term": "Software Manufacturing/Software Deployment",
      "count": 2
    },
    {
      "term": "Finished device change control",
      "count": 1
    },
    {
      "term": "PMA",
      "count": 1
    },
    {
      "term": "Software Design Change",
      "count": 1
    },
    {
      "term": "Software design (manufacturing process)",
      "count": 1
    }
  ]
}