{
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        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Composition_55d92f43-e328-4011-bbcf-744e3afd954f\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition 55d92f43-e328-4011-bbcf-744e3afd954f</b></p><a name=\"55d92f43-e328-4011-bbcf-744e3afd954f\"> </a><a name=\"hc55d92f43-e328-4011-bbcf-744e3afd954f\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ectd-composition-sp4151.html\">eCTD Specification</a></p></div><p><b>identifier</b>: ExampleSpecification2</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/ICHContextOfUse ich_3.2.s.4.1}\">m3.2.s.4.1 specification</span></p><p><b>date</b>: 2023-12-15 22:36:51+0000</p><p><b>author</b>: <a href=\"Bundle-BatchFormulaBundle.html#urn-uuid-4f3e9af1-306b-4fad-bf04-7881400b266a\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></p><p><b>title</b>: Quality Specification for an API</p></div>"
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      "author" : [{
        "reference" : "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"
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      "title" : "Quality Specification for an API",
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        "title" : "32S41",
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      "resourceType" : "PlanDefinition",
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      "meta" : {
        "profile" : ["http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"]
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      "text" : {
        "status" : "extensions",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"PlanDefinition_cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93\"> </a>\n<div>\n    <table class=\"grid dict\">\n        \n        <tr>\n            <th scope=\"row\"><b>Id: </b></th>\n            <td style=\"padding-left: 4px;\">cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93</td>\n        </tr>\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Version: </b></th>\n            <td style=\"padding-left: 4px;\">1.0</td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\">\n                <b>\n                    \n                        \n                    \n                </b>\n            </th>\n            <td style=\"padding-left: 4px;\">\n                \n                <p style=\"margin-bottom: 5px;\">\n                    <span>ExampleSpecification2</span>\n                </p>\n                \n            </td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Title: </b></th>\n            <td style=\"padding-left: 4px;\">Quality Specification for an API</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Type: </b></th>\n            <td style=\"padding-left: 4px;\">\n                \n                    \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>system: </b> <span><a href=\"http://terminology.hl7.org/6.4.0/CodeSystem-plan-definition-type.html\">http://terminology.hl7.org/CodeSystem/plan-definition-type</a></span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>code: </b> <span>workflow-definition</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Workflow Definition</span>\n                        </p>\n                        \n                    \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>system: </b> <span><a href=\"https://ncit.nci.nih.gov/ncitbrowser/pages/home.jsf\">http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</a></span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>code: </b> <span>C134022</span>\n                        </p>\n                        \n                        \n                        <p style=\"margin-bottom: 5px;\">\n                            <b>display: </b> <span>Drug Substance</span>\n                        </p>\n                        \n                    \n                \n                \n            </td>\n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Subject: </b></th>\n            \n            \n            <td style=\"padding-left: 4px;\">\n                \n                <p style=\"margin-bottom: 5px;\">\n                    <b>reference: </b> <span>urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf</span>\n                </p>\n                \n                \n                \n            </td>\n            \n        </tr>\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Date: </b></th>\n            <td style=\"padding-left: 4px;\">2022-12-08</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Approval Date: </b></th>\n            <td style=\"padding-left: 4px;\">2022-12-08</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Actions: </b></th>\n            <td style=\"padding-left: 4px;\">\n                <table class=\"grid-dict\">\n                    \n                    <tr>\n                        <td>\n                            \n                            <b>Single Stage Microbiological Examination of Nonsterile Products:</b> \n                            \n                            <br/>\n                            \n                            \n                            \n                            <b>Then:</b>\n                            <table class=\"grid-dict\">\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Staphylococcus aureus:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Pseudomonas aeruginosa:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Bacillus subtilis:</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Total Aerobic Microbial Count (TAMC):</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                                <tr>\n                                    <td>\n                                        \n                                        <b> Total Yeasts and Molds Count (TYMC):</b>\n                                        \n                                        \n                                        <br/>\n                                        \n                                        \n                                        \n                                        \n                                        \n                                    </td>\n                                </tr>\n                                \n                            </table>\n                            \n                        </td>\n                    </tr>\n                    \n                </table>\n            </td>\n        </tr>\n        \n    </table>\n</div>\n</div>"
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      "extension" : [{
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            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C134010",
            "display" : "Tentatively Approved"
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        }
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        "url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension",
        "valueMarkdown" : "This API is is currently characterized through a standard battery of physicochemical characterzation tests."
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      "identifier" : [{
        "value" : "ExampleSpecification2"
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      "version" : "1.0",
      "title" : "Quality Specification for an API",
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          "code" : "workflow-definition",
          "display" : "Workflow Definition"
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        {
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C134022",
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      "status" : "active",
      "subjectReference" : {
        "reference" : "urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf"
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      "date" : "2022-12-08",
      "approvalDate" : "2022-12-08",
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          "text" : "Negative"
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        "addresses" : [{
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            "value" : 10,
            "comparator" : "<=",
            "unit" : "colony forming unit",
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        {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
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            "unit" : "colony forming unit",
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      "action" : [{
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        "prefix" : "Single Stage",
        "title" : "Microbiological Examination of Nonsterile Products",
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          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C96102",
            "display" : "Compendial"
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          "text" : "Visual"
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        "reason" : [{
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            "url" : "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension",
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        "documentation" : [{
          "type" : "documentation",
          "label" : "USP <61>"
        }],
        "action" : [{
          "linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
          "title" : "Staphylococcus aureus",
          "goalId" : ["b304ed45-5295-4082-9827-f20e1ff0d1d3"]
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        {
          "linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
          "title" : "Pseudomonas aeruginosa",
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        },
        {
          "linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
          "title" : "Bacillus subtilis",
          "goalId" : ["2abf1f19-e1b1-42e4-b943-79f5fa1642fe"]
        },
        {
          "linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
          "title" : "Total Aerobic Microbial Count (TAMC)",
          "goalId" : ["c0ed4a79-8f40-4d26-8845-4cea166fb627"]
        },
        {
          "linkId" : "997a8ec6-eabf-41a3-b166-ddc3dfb35c27",
          "title" : "Total Yeasts and Molds Count (TYMC)",
          "goalId" : ["442983b5-bbc3-4534-9f1b-5ae5e4c531c1"]
        }]
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  },
  {
    "fullUrl" : "urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf",
    "resource" : {
      "resourceType" : "SubstanceDefinition",
      "id" : "580c28ac-1a2c-49fa-9be3-de997da5edcf",
      "meta" : {
        "profile" : ["http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_580c28ac-1a2c-49fa-9be3-de997da5edcf\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 580c28ac-1a2c-49fa-9be3-de997da5edcf</b></p><a name=\"580c28ac-1a2c-49fa-9be3-de997da5edcf\"> </a><a name=\"hc580c28ac-1a2c-49fa-9be3-de997da5edcf\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-pqcmc-routine-drug-substance.html\">Drug Substance Handle</a></p></div><p><b>identifier</b>: P-Isobutylhydratropic Acid</p><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}\">USP-NF</span></p><p><b>manufacturer</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-e99bddfa-c1b5-435b-bbe8-24816b4e23e5\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></p><p><b>supplier</b>: <a href=\"Bundle-ControlMaterialsBundle.html#urn-uuid-d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\">Bundle: identifier = UUID:7ce2088d-d281-4e2f-9a25-120a1f9805d1; type = document; timestamp = 2023-12-05 01:34:39+0000</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov WK2XYI10QM}\">WK2XYI10QM</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>IBUPROFENPIRIN</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table></div>"
      },
      "identifier" : [{
        "value" : "P-Isobutylhydratropic Acid"
      }],
      "classification" : [{
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C48807",
          "display" : "Chemical"
        }]
      }],
      "grade" : [{
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C134006",
          "display" : "USP-NF"
        }]
      }],
      "manufacturer" : [{
        "reference" : "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"
      }],
      "supplier" : [{
        "reference" : "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"
      }],
      "code" : [{
        "code" : {
          "coding" : [{
            "system" : "http://fdasis.nlm.nih.gov",
            "code" : "WK2XYI10QM"
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      }],
      "name" : [{
        "name" : "IBUPROFENPIRIN",
        "type" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C203355",
            "display" : "GSRS Preferred Term"
          }]
        },
        "preferred" : true
      }]
    }
  },
  {
    "fullUrl" : "urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a",
    "resource" : {
      "resourceType" : "Organization",
      "id" : "4f3e9af1-306b-4fad-bf04-7881400b266a",
      "meta" : {
        "profile" : ["http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a</b></p><a name=\"4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><a name=\"hc4f3e9af1-306b-4fad-bf04-7881400b266a\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/143265222</p><p><b>name</b>: Wunderwerke</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478</td></tr></table></div>"
      },
      "identifier" : [{
        "type" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C134003",
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          }]
        },
        "system" : "urn:oid:1.3.6.1.4.1.519.1",
        "value" : "143265222"
      }],
      "name" : "Wunderwerke",
      "contact" : [{
        "address" : {
          "type" : "postal",
          "text" : "Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478",
          "line" : ["123 Scenic Road"],
          "city" : "Bridgeport",
          "state" : "CT",
          "postalCode" : "65478",
          "country" : "USA"
        }
      }]
    }
  },
  {
    "fullUrl" : "urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5",
    "resource" : {
      "resourceType" : "Organization",
      "id" : "e99bddfa-c1b5-435b-bbe8-24816b4e23e5",
      "meta" : {
        "profile" : ["http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_e99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization e99bddfa-c1b5-435b-bbe8-24816b4e23e5</b></p><a name=\"e99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><a name=\"hce99bddfa-c1b5-435b-bbe8-24816b4e23e5\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/143265222, FEI/6981397</p><p><b>name</b>: Vidinaid</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA</td></tr></table></div>"
      },
      "identifier" : [{
        "type" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C134003",
            "display" : "DUNS"
          }]
        },
        "system" : "urn:oid:1.3.6.1.4.1.519.1",
        "value" : "143265222"
      },
      {
        "type" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C134004",
            "display" : "FEI"
          }]
        },
        "system" : "urn:oid:2.16.840.1.113883.4.82",
        "value" : "6981397"
      }],
      "name" : "Vidinaid",
      "contact" : [{
        "address" : {
          "type" : "postal",
          "text" : "Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA",
          "line" : ["100 Stillwater Avenue",
          "Building #2"],
          "city" : "Bangor",
          "state" : "ME",
          "postalCode" : "04401",
          "country" : "USA"
        }
      }]
    }
  },
  {
    "fullUrl" : "urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049",
    "resource" : {
      "resourceType" : "Organization",
      "id" : "d9e7c2f7-0f59-4645-bb6d-5a8dd2425049",
      "meta" : {
        "profile" : ["http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"]
      },
      "text" : {
        "status" : "generated",
        "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Organization_d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Organization d9e7c2f7-0f59-4645-bb6d-5a8dd2425049</b></p><a name=\"d9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><a name=\"hcd9e7c2f7-0f59-4645-bb6d-5a8dd2425049\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-cmc-organization.html\">Basic Organization</a></p></div><p><b>identifier</b>: DUNS/173265332</p><p><b>name</b>: Mega Chem Supply</p><h3>Contacts</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Address</b></td></tr><tr><td style=\"display: none\">*</td><td>Mega Chem Supply, 350 W Main Street, Rochester, NY, United States</td></tr></table></div>"
      },
      "identifier" : [{
        "type" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C134003",
            "display" : "DUNS"
          }]
        },
        "system" : "urn:oid:1.3.6.1.4.1.519.1",
        "value" : "173265332"
      }],
      "name" : "Mega Chem Supply",
      "contact" : [{
        "address" : {
          "type" : "postal",
          "text" : "Mega Chem Supply, 350 W Main Street, Rochester, NY, United States",
          "line" : ["350 W Main Street"],
          "city" : "Rochester",
          "state" : "NY",
          "postalCode" : "14608",
          "country" : "USA"
        }
      }]
    }
  }]
}