{
  "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": "Device Design",
      "count": 413
    },
    {
      "term": "Process control",
      "count": 394
    },
    {
      "term": "Other",
      "count": 360
    },
    {
      "term": "Nonconforming Material/Component",
      "count": 325
    },
    {
      "term": "Under Investigation by firm",
      "count": 240
    },
    {
      "term": "Component design/selection",
      "count": 152
    },
    {
      "term": "Software design",
      "count": 86
    },
    {
      "term": "Process design",
      "count": 57
    },
    {
      "term": "Labeling mix-ups",
      "count": 53
    },
    {
      "term": "Labeling design",
      "count": 52
    },
    {
      "term": "Employee error",
      "count": 42
    },
    {
      "term": "Equipment maintenance",
      "count": 40
    },
    {
      "term": "Mixed-up of materials/components",
      "count": 40
    },
    {
      "term": "Pending",
      "count": 38
    },
    {
      "term": "Component change control",
      "count": 33
    },
    {
      "term": "Use error",
      "count": 25
    },
    {
      "term": "Error in labeling",
      "count": 24
    },
    {
      "term": "Storage",
      "count": 23
    },
    {
      "term": "Labeling Change Control",
      "count": 17
    },
    {
      "term": "Process change control",
      "count": 17
    },
    {
      "term": "Unknown/Undetermined by firm",
      "count": 16
    },
    {
      "term": "Packaging process control",
      "count": 15
    },
    {
      "term": "Software Design Change",
      "count": 15
    },
    {
      "term": "Software change control",
      "count": 14
    },
    {
      "term": "Vendor change control",
      "count": 14
    },
    {
      "term": "Software design (manufacturing process)",
      "count": 13
    },
    {
      "term": "Labeling False and Misleading",
      "count": 8
    },
    {
      "term": "Material/Component Contamination",
      "count": 8
    },
    {
      "term": "Packaging",
      "count": 8
    },
    {
      "term": "Package design/selection",
      "count": 6
    },
    {
      "term": "Release of Material/Component prior to receiving test results",
      "count": 6
    },
    {
      "term": "Packaging change control",
      "count": 5
    },
    {
      "term": "No Marketing Application",
      "count": 4
    },
    {
      "term": "Software Manufacturing/Software Deployment",
      "count": 4
    },
    {
      "term": "PMA",
      "count": 3
    },
    {
      "term": "Environmental control",
      "count": 2
    },
    {
      "term": "Software in the Use Environment",
      "count": 2
    },
    {
      "term": "Incorrect or no expiration date",
      "count": 1
    },
    {
      "term": "Reprocessing Controls",
      "count": 1
    }
  ]
}