Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

## : 3.2.S.4.1 Bundle - XML Representation

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    <Bundle xmlns="http://hl7.org/fhir">
      <id value="SpecificationSubstanceBundle"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-sp4151"/>
      </meta>
      <identifier>
        <system value="urn:ietf:rfc:3986"/>
        <value value="urn:uuid:3e9cc7a1-e157-4b46-980a-33a8e50dcf65"/>
      </identifier>
      <type value="document"/>
      <timestamp value="2023-12-15T22:36:51.299Z"/>
      <entry>
        <fullUrl value="urn:uuid:55d92f43-e328-4011-bbcf-744e3afd954f"/>
        <resource>
          <Composition>
            <id value="55d92f43-e328-4011-bbcf-744e3afd954f"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151"/>
            </meta>
            <text>
              <status value="generated"/>
              <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>
            </text>
            <identifier>
              <value value="ExampleSpecification2"/>
            </identifier>
            <status value="final"/>
            <type>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/ICHContextOfUse"/>
                <code value="ich_3.2.s.4.1"/>
                <display value="m3.2.s.4.1 specification"/>
              </coding>
            </type>
            <date value="2023-12-15T22:36:51.299Z"/>
            <author>
              <reference value="urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"/>
            </author>
            <title value="Quality Specification for an API"/>
            <section>
              <title value="32S41"/>
              <entry>
                <reference value="urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"/>
              </entry>
            </section>
          </Composition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"/>
        <resource>
          <PlanDefinition>
            <id value="cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification"/>
            </meta>
            <text>
              <status value="extensions"/>
              <div xmlns="http://www.w3.org/1999/xhtml"><a name="PlanDefinition_cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93"> </a>
    <div>
        <table class="grid dict">

            <tr>
                <th scope="row"><b>Id: </b></th>
                <td style="padding-left: 4px;">cc82a0ce-b72f-4d58-8ea0-6f323e2a9a93</td>
            </tr>

            <tr>
                <th scope="row"><b>Version: </b></th>
                <td style="padding-left: 4px;">1.0</td>
            </tr>

            <tr>
                <th scope="row">
                    <b>

                    </b>
                </th>
                <td style="padding-left: 4px;">

                    <p style="margin-bottom: 5px;">
                        <span>ExampleSpecification2</span>
                    </p>

                </td>
            </tr>

            <tr>
                <th scope="row"><b>Title: </b></th>
                <td style="padding-left: 4px;">Quality Specification for an API</td>
            </tr>

            <tr>
                <th scope="row"><b>Type: </b></th>
                <td style="padding-left: 4px;">

                            <p style="margin-bottom: 5px;">
                                <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>
                            </p>

                            <p style="margin-bottom: 5px;">
                                <b>code: </b> <span>workflow-definition</span>
                            </p>

                            <p style="margin-bottom: 5px;">
                                <b>display: </b> <span>Workflow Definition</span>
                            </p>

                            <p style="margin-bottom: 5px;">
                                <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>
                            </p>

                            <p style="margin-bottom: 5px;">
                                <b>code: </b> <span>C134022</span>
                            </p>

                            <p style="margin-bottom: 5px;">
                                <b>display: </b> <span>Drug Substance</span>
                            </p>

                </td>
            </tr>

            <tr>
                <th scope="row"><b>Subject: </b></th>

                <td style="padding-left: 4px;">

                    <p style="margin-bottom: 5px;">
                        <b>reference: </b> <span>urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf</span>
                    </p>

                </td>

            </tr>

            <tr>
                <th scope="row"><b>Date: </b></th>
                <td style="padding-left: 4px;">2022-12-08</td>
            </tr>

            <tr>
                <th scope="row"><b>Approval Date: </b></th>
                <td style="padding-left: 4px;">2022-12-08</td>
            </tr>

            <tr>
                <th scope="row"><b>Actions: </b></th>
                <td style="padding-left: 4px;">
                    <table class="grid-dict">

                        <tr>
                            <td>

                                <b>Single Stage Microbiological Examination of Nonsterile Products:</b>

                                <br/>

                                <b>Then:</b>
                                <table class="grid-dict">

                                    <tr>
                                        <td>

                                            <b> Staphylococcus aureus:</b>

                                            <br/>

                                        </td>
                                    </tr>

                                    <tr>
                                        <td>

                                            <b> Pseudomonas aeruginosa:</b>

                                            <br/>

                                        </td>
                                    </tr>

                                    <tr>
                                        <td>

                                            <b> Bacillus subtilis:</b>

                                            <br/>

                                        </td>
                                    </tr>

                                    <tr>
                                        <td>

                                            <b> Total Aerobic Microbial Count (TAMC):</b>

                                            <br/>

                                        </td>
                                    </tr>

                                    <tr>
                                        <td>

                                            <b> Total Yeasts and Molds Count (TYMC):</b>

                                            <br/>

                                        </td>
                                    </tr>

                                </table>

                            </td>
                        </tr>

                    </table>
                </td>
            </tr>

        </table>
    </div>
    </div>
            </text>
            <extension
                       url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension">
              <valueCodeableConcept>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134010"/>
                  <display value="Tentatively Approved"/>
                </coding>
              </valueCodeableConcept>
            </extension>
            <extension
                       url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension">
              <valueMarkdown
                             value="This API is is currently characterized through a standard battery of physicochemical characterzation tests."/>
            </extension>
            <identifier>
              <value value="ExampleSpecification2"/>
            </identifier>
            <version value="1.0"/>
            <title value="Quality Specification for an API"/>
            <type>
              <coding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/plan-definition-type"/>
                <code value="workflow-definition"/>
                <display value="Workflow Definition"/>
              </coding>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C134022"/>
                <display value="Drug Substance"/>
              </coding>
            </type>
            <status value="active"/>
            <subjectReference>
              <reference value="urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf"/>
            </subjectReference>
            <date value="2022-12-08"/>
            <approvalDate value="2022-12-08"/>
            <goal id="b304ed45-5295-4082-9827-f20e1ff0d1d3">
              <description>
                <text value="Negative"/>
              </description>
              <addresses>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134029"/>
                  <display value="Release"/>
                </coding>
              </addresses>
              <addresses>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134030"/>
                  <display value="Stability"/>
                </coding>
              </addresses>
              <target>
                <detailString value="Negative"/>
              </target>
            </goal>
            <goal id="d4e38c52-30f6-4bb7-ab84-99439a7266ce">
              <description>
                <text value="Negative"/>
              </description>
              <addresses>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134029"/>
                  <display value="Release"/>
                </coding>
              </addresses>
              <addresses>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134030"/>
                  <display value="Stability"/>
                </coding>
              </addresses>
              <target>
                <detailString value="Negative"/>
              </target>
            </goal>
            <goal id="2abf1f19-e1b1-42e4-b943-79f5fa1642fe">
              <description>
                <text value="Negative"/>
              </description>
              <addresses>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134029"/>
                  <display value="Release"/>
                </coding>
              </addresses>
              <addresses>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134030"/>
                  <display value="Stability"/>
                </coding>
              </addresses>
              <target>
                <detailString value="Negative"/>
              </target>
            </goal>
            <goal id="c0ed4a79-8f40-4d26-8845-4cea166fb627">
              <description>
                <text value="NMT 10 colony-forming units"/>
              </description>
              <addresses>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134029"/>
                  <display value="Release"/>
                </coding>
              </addresses>
              <addresses>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134030"/>
                  <display value="Stability"/>
                </coding>
              </addresses>
              <target>
                <detailQuantity>
                  <value value="10"/>
                  <comparator value="&lt;="/>
                  <unit value="colony forming unit"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="[CFU]"/>
                </detailQuantity>
              </target>
            </goal>
            <goal id="442983b5-bbc3-4534-9f1b-5ae5e4c531c1">
              <description>
                <text value="NMT 100 colony-forming units"/>
              </description>
              <addresses>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134029"/>
                  <display value="Release"/>
                </coding>
              </addresses>
              <addresses>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134030"/>
                  <display value="Stability"/>
                </coding>
              </addresses>
              <target>
                <detailQuantity>
                  <value value="100"/>
                  <comparator value="&lt;="/>
                  <unit value="colony forming unit"/>
                  <system value="http://unitsofmeasure.org"/>
                  <code value="[CFU]"/>
                </detailQuantity>
              </target>
            </goal>
            <action id="997a8ec6-eabf-41a3-b166-ddc3dfb35c27">
              <prefix value="Single Stage"/>
              <title value="Microbiological Examination of Nonsterile Products"/>
              <code>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C96102"/>
                  <display value="Compendial"/>
                </coding>
                <text value="Visual"/>
              </code>
              <reason>
                <extension
                           url="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension">
                  <valuePositiveInt value="1"/>
                </extension>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134256"/>
                  <display value="Microbial Limits"/>
                </coding>
              </reason>
              <documentation>
                <type value="documentation"/>
                <label value="USP &lt;61&gt;"/>
              </documentation>
              <action>
                <linkId value="997a8ec6-eabf-41a3-b166-ddc3dfb35c27"/>
                <title value="Staphylococcus aureus"/>
                <goalId value="b304ed45-5295-4082-9827-f20e1ff0d1d3"/>
              </action>
              <action>
                <linkId value="997a8ec6-eabf-41a3-b166-ddc3dfb35c27"/>
                <title value="Pseudomonas aeruginosa"/>
                <goalId value="d4e38c52-30f6-4bb7-ab84-99439a7266ce"/>
              </action>
              <action>
                <linkId value="997a8ec6-eabf-41a3-b166-ddc3dfb35c27"/>
                <title value="Bacillus subtilis"/>
                <goalId value="2abf1f19-e1b1-42e4-b943-79f5fa1642fe"/>
              </action>
              <action>
                <linkId value="997a8ec6-eabf-41a3-b166-ddc3dfb35c27"/>
                <title value="Total Aerobic Microbial Count (TAMC)"/>
                <goalId value="c0ed4a79-8f40-4d26-8845-4cea166fb627"/>
              </action>
              <action>
                <linkId value="997a8ec6-eabf-41a3-b166-ddc3dfb35c27"/>
                <title value="Total Yeasts and Molds Count (TYMC)"/>
                <goalId value="442983b5-bbc3-4534-9f1b-5ae5e4c531c1"/>
              </action>
            </action>
          </PlanDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:580c28ac-1a2c-49fa-9be3-de997da5edcf"/>
        <resource>
          <SubstanceDefinition>
            <id value="580c28ac-1a2c-49fa-9be3-de997da5edcf"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"/>
            </meta>
            <text>
              <status value="generated"/>
              <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>
            </text>
            <identifier>
              <value value="P-Isobutylhydratropic Acid"/>
            </identifier>
            <classification>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C48807"/>
                <display value="Chemical"/>
              </coding>
            </classification>
            <grade>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C134006"/>
                <display value="USP-NF"/>
              </coding>
            </grade>
            <manufacturer>
              <reference value="urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"/>
            </manufacturer>
            <supplier>
              <reference value="urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"/>
            </supplier>
            <code>
              <code>
                <coding>
                  <system value="http://fdasis.nlm.nih.gov"/>
                  <code value="WK2XYI10QM"/>
                </coding>
              </code>
            </code>
            <name>
              <name value="IBUPROFENPIRIN"/>
              <type>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C203355"/>
                  <display value="GSRS Preferred Term"/>
                </coding>
              </type>
              <preferred value="true"/>
            </name>
          </SubstanceDefinition>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:4f3e9af1-306b-4fad-bf04-7881400b266a"/>
        <resource>
          <Organization>
            <id value="4f3e9af1-306b-4fad-bf04-7881400b266a"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
            </meta>
            <text>
              <status value="generated"/>
              <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>
            </text>
            <identifier>
              <type>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134003"/>
                  <display value="DUNS"/>
                </coding>
              </type>
              <system value="urn:oid:1.3.6.1.4.1.519.1"/>
              <value value="143265222"/>
            </identifier>
            <name value="Wunderwerke"/>
            <contact>
              <address>
                <type value="postal"/>
                <text
                      value="Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478"/>
                <line value="123 Scenic Road"/>
                <city value="Bridgeport"/>
                <state value="CT"/>
                <postalCode value="65478"/>
                <country value="USA"/>
              </address>
            </contact>
          </Organization>
        </resource>
      </entry>
      <entry>
        <fullUrl value="urn:uuid:e99bddfa-c1b5-435b-bbe8-24816b4e23e5"/>
        <resource>
          <Organization>
            <id value="e99bddfa-c1b5-435b-bbe8-24816b4e23e5"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
            </meta>
            <text>
              <status value="generated"/>
              <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>
            </text>
            <identifier>
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                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134003"/>
                  <display value="DUNS"/>
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              </type>
              <system value="urn:oid:1.3.6.1.4.1.519.1"/>
              <value value="143265222"/>
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            <identifier>
              <type>
                <coding>
                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134004"/>
                  <display value="FEI"/>
                </coding>
              </type>
              <system value="urn:oid:2.16.840.1.113883.4.82"/>
              <value value="6981397"/>
            </identifier>
            <name value="Vidinaid"/>
            <contact>
              <address>
                <type value="postal"/>
                <text
                      value="Vidinaid, 100 Stillwater Avenue, Building #2, Bangor, ME, USA"/>
                <line value="100 Stillwater Avenue"/>
                <line value="Building #2"/>
                <city value="Bangor"/>
                <state value="ME"/>
                <postalCode value="04401"/>
                <country value="USA"/>
              </address>
            </contact>
          </Organization>
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      </entry>
      <entry>
        <fullUrl value="urn:uuid:d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"/>
        <resource>
          <Organization>
            <id value="d9e7c2f7-0f59-4645-bb6d-5a8dd2425049"/>
            <meta>
              <profile
                       value="http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization"/>
            </meta>
            <text>
              <status value="generated"/>
              <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>
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                  <system
                          value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                  <code value="C134003"/>
                  <display value="DUNS"/>
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              <system value="urn:oid:1.3.6.1.4.1.519.1"/>
              <value value="173265332"/>
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            <name value="Mega Chem Supply"/>
            <contact>
              <address>
                <type value="postal"/>
                <text
                      value="Mega Chem Supply, 350 W Main Street, Rochester, NY, United States"/>
                <line value="350 W Main Street"/>
                <city value="Rochester"/>
                <state value="NY"/>
                <postalCode value="14608"/>
                <country value="USA"/>
              </address>
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          </Organization>
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      </entry>
    </Bundle>