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Warning Letters | FDA

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</select> <input type="text" id="field_change_date_closeout_letter" name="field_change_date_closeout_letter" value="" style="display:none"> <input type="text" id="field_change_date_response_letter" name="field_change_date_response_letter" value="" style="display:none"> </div> </div> </div> <div class="row"> <div class="col-sm-6 lcds-datatable-filter__group"> <div class="form-group"> <div class="form-item js-form-item form-type-select js-form-type-select form-item-field-change-date-2 js-form-item-field-change-date-2 form-group"> <label for="edit-field-change-date-2" class="control-label">Posted Date</label> <span class="select-wrapper"><select data-drupal-selector="edit-field-change-date-2" class="form-select form-control" id="edit-field-change-date-2" name="field_change_date_2"><option value="All" selected="selected">- Any -</option><option value="1">Last 7 Days</option><option value="2">Last 30 Days</option><option value="3">Last 60 Days</option><option value="4">Last 90 Days</option></select></span> </div> </div> </div> <div class="col-sm-6 lcds-datatable-filter__group"> <div class="form-group"> <label class="control-label" for="field_letter_issue_datetime_2">Year</label> <select class='form-control' id="field_letter_issue_datetime_2" name="field_letter_issue_datetime_2"> <option selected value="">- Any -</option> </select> </div> </div> </div> <input id="datatable-reset" type="reset" class='btn btn-default float-right' value="Clear Filters" /> </div> </div> </div> </div> </div> </form> </div> </div> <div class="view-content"> <table class="lcds-datatable table table-bordered cols-8 responsive-enabled" id="datatable"> <thead> <tr> <th id="view-field-change-date-2-table-column" aria-sort="descending" class="views-field views-field-field-change-date-2 is-active" scope="col">Posted Date</th> <th id="view-field-letter-issue-datetime-table-column" class="views-field views-field-field-letter-issue-datetime" scope="col">Letter Issue Date</th> <th class="priority-medium views-field views-field-company-name" id="view-company-name-table-column" scope="col">Company Name</th> <th class="priority-low views-field views-field-field-building" id="view-field-building-table-column" scope="col">Issuing Office</th> <th class="priority-low views-field views-field-field-detailed-description-2" id="view-field-detailed-description-2-table-column" scope="col">Subject</th> <th id="view-field-change-date-response-letter-table-column" class="views-field views-field-field-change-date-response-letter" scope="col">Response Letter</th> <th id="view-field-change-date-closeout-letter-table-column" class="views-field views-field-field-change-date-closeout-letter" scope="col">Closeout Letter</th> <th class="all views-field views-field-search-api-excerpt" id="view-search-api-excerpt-table-column" scope="col">Excerpt</th> </tr> </thead> <tbody> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-11-19T14:20:00Z">11/19/2024</time> </td> <td headers="view-field-letter-issue-datetime-table-column" class="views-field views-field-field-letter-issue-datetime"><time datetime="2024-11-06T05:00:00Z">11/06/2024</time> </td> <td class="priority-medium views-field views-field-company-name" headers="view-company-name-table-column"><a href="/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/unexo-lifesciences-private-limited-688163-11062024">Unexo Lifesciences, Private Limited</a> </td> <td class="priority-low views-field views-field-field-building" headers="view-field-building-table-column">Center for Drug Evaluation and Research (CDER) </td> <td class="priority-low views-field views-field-field-detailed-description-2" headers="view-field-detailed-description-2-table-column">CGMP/Finished Pharmaceuticals/Adulterated </td> <td headers="view-field-change-date-response-letter-table-column" class="views-field views-field-field-change-date-response-letter"> </td> <td headers="view-field-change-date-closeout-letter-table-column" class="views-field views-field-field-change-date-closeout-letter"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-11-19T14:20:00Z">11/19/2024</time> </td> <td headers="view-field-letter-issue-datetime-table-column" class="views-field views-field-field-letter-issue-datetime"><time datetime="2024-11-05T05:00:00Z">11/05/2024</time> </td> <td class="priority-medium views-field views-field-company-name" headers="view-company-name-table-column"><a href="/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/colgate-palmolivetoms-maine-inc-687043-11052024">Colgate-Palmolive/Tom&#039;s of Maine, Inc.</a> </td> <td class="priority-low views-field views-field-field-building" headers="view-field-building-table-column">Center for Drug Evaluation and Research (CDER) </td> <td class="priority-low views-field views-field-field-detailed-description-2" headers="view-field-detailed-description-2-table-column">CGMP/Finished Pharmaceuticals/Adulterated </td> <td headers="view-field-change-date-response-letter-table-column" class="views-field views-field-field-change-date-response-letter"> </td> <td headers="view-field-change-date-closeout-letter-table-column" class="views-field views-field-field-change-date-closeout-letter"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-11-19T14:20:00Z">11/19/2024</time> </td> <td headers="view-field-letter-issue-datetime-table-column" class="views-field views-field-field-letter-issue-datetime"><time datetime="2024-11-07T05:00:00Z">11/07/2024</time> </td> <td class="priority-medium views-field views-field-company-name" headers="view-company-name-table-column"><a href="/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/originitalia-srl-687935-11072024">Originitalia SRL</a> </td> <td class="priority-low views-field views-field-field-building" headers="view-field-building-table-column">Center for Drug Evaluation and Research (CDER) </td> <td class="priority-low views-field views-field-field-detailed-description-2" headers="view-field-detailed-description-2-table-column">CGMP/Finished Pharmaceuticals/Adulterated </td> <td headers="view-field-change-date-response-letter-table-column" class="views-field views-field-field-change-date-response-letter"> </td> <td headers="view-field-change-date-closeout-letter-table-column" class="views-field views-field-field-change-date-closeout-letter"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-11-19T14:20:00Z">11/19/2024</time> </td> <td headers="view-field-letter-issue-datetime-table-column" class="views-field views-field-field-letter-issue-datetime"><time datetime="2024-10-30T04:00:00Z">10/30/2024</time> </td> <td class="priority-medium views-field views-field-company-name" headers="view-company-name-table-column"><a href="/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tianjin-darentang-jingwanhong-pharmaceutical-co-ltd-683619-10302024">Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd.</a> </td> <td class="priority-low views-field views-field-field-building" headers="view-field-building-table-column">Center for Drug Evaluation and Research (CDER) </td> <td class="priority-low views-field views-field-field-detailed-description-2" headers="view-field-detailed-description-2-table-column">CGMP/Finished Pharmaceuticals/Adulterated </td> <td headers="view-field-change-date-response-letter-table-column" class="views-field views-field-field-change-date-response-letter"> </td> <td headers="view-field-change-date-closeout-letter-table-column" class="views-field views-field-field-change-date-closeout-letter"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-11-19T14:20:00Z">11/19/2024</time> </td> <td headers="view-field-letter-issue-datetime-table-column" class="views-field views-field-field-letter-issue-datetime"><time datetime="2024-11-01T04:00:00Z">11/01/2024</time> </td> <td class="priority-medium views-field views-field-company-name" headers="view-company-name-table-column"><a href="/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/frontier-biologics-llc-686059-11012024">Frontier Biologics, LLC</a> </td> <td class="priority-low views-field views-field-field-building" headers="view-field-building-table-column">Center for Biologics Evaluation and Research </td> <td class="priority-low views-field views-field-field-detailed-description-2" headers="view-field-detailed-description-2-table-column">Unapproved New Drug/Unlicensed Biological Product Violations<br /> </td> <td headers="view-field-change-date-response-letter-table-column" class="views-field views-field-field-change-date-response-letter"> </td> <td headers="view-field-change-date-closeout-letter-table-column" class="views-field views-field-field-change-date-closeout-letter"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-11-19T14:20:00Z">11/19/2024</time> </td> <td headers="view-field-letter-issue-datetime-table-column" class="views-field views-field-field-letter-issue-datetime"><time datetime="2024-11-06T05:00:00Z">11/06/2024</time> </td> <td class="priority-medium views-field views-field-company-name" headers="view-company-name-table-column"><a href="/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/richard-w-foltin-phd-690189-11062024">Richard W. Foltin, Ph.D. </a> </td> <td class="priority-low views-field views-field-field-building" headers="view-field-building-table-column">Center for Drug Evaluation and Research (CDER) </td> <td class="priority-low views-field views-field-field-detailed-description-2" headers="view-field-detailed-description-2-table-column">Clinical Investigator (Sponsor) </td> <td headers="view-field-change-date-response-letter-table-column" class="views-field views-field-field-change-date-response-letter"> </td> <td headers="view-field-change-date-closeout-letter-table-column" class="views-field views-field-field-change-date-closeout-letter"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-11-19T14:20:00Z">11/19/2024</time> </td> <td headers="view-field-letter-issue-datetime-table-column" class="views-field views-field-field-letter-issue-datetime"><time datetime="2024-05-13T04:00:00Z">05/13/2024</time> </td> <td class="priority-medium views-field views-field-company-name" headers="view-company-name-table-column"><a href="/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/golden-shrimp-seafood-joint-stock-company-682535-05132024">Golden Shrimp Seafood Joint Stock Company</a> </td> <td class="priority-low views-field views-field-field-building" headers="view-field-building-table-column">Center for Food Safety and Applied Nutrition </td> <td class="priority-low views-field views-field-field-detailed-description-2" headers="view-field-detailed-description-2-table-column">Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions </td> <td headers="view-field-change-date-response-letter-table-column" class="views-field views-field-field-change-date-response-letter"> </td> <td headers="view-field-change-date-closeout-letter-table-column" class="views-field views-field-field-change-date-closeout-letter"><a href="/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/golden-shrimp-seafood-joint-stock-company-682535-08222024"><time datetime="2024-11-22T05:00:00Z">11/22/2024</time> </a> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-11-12T14:20:00Z">11/12/2024</time> </td> <td headers="view-field-letter-issue-datetime-table-column" class="views-field views-field-field-letter-issue-datetime"><time datetime="2024-11-01T04:00:00Z">11/01/2024</time> </td> <td class="priority-medium views-field views-field-company-name" headers="view-company-name-table-column"><a href="/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/owens-minor-inc-dba-american-contract-systems-inc-695683-11012024">Owens &amp; Minor, Inc. dba American Contract Systems, Inc.</a> </td> <td class="priority-low views-field views-field-field-building" headers="view-field-building-table-column">Center for Devices and Radiological Health </td> <td class="priority-low views-field views-field-field-detailed-description-2" headers="view-field-detailed-description-2-table-column">CGMP/QSR/Medical Devices/Adulterated<br /> </td> <td headers="view-field-change-date-response-letter-table-column" class="views-field views-field-field-change-date-response-letter"> </td> <td headers="view-field-change-date-closeout-letter-table-column" class="views-field views-field-field-change-date-closeout-letter"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-11-12T14:20:00Z">11/12/2024</time> </td> <td headers="view-field-letter-issue-datetime-table-column" class="views-field views-field-field-letter-issue-datetime"><time datetime="2024-11-05T05:00:00Z">11/05/2024</time> </td> <td class="priority-medium views-field views-field-company-name" headers="view-company-name-table-column"><a href="/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/multaler-et-cie-sas-685009-11052024">Multaler et Cie SAS</a> </td> <td class="priority-low views-field views-field-field-building" headers="view-field-building-table-column">Center for Drug Evaluation and Research (CDER) </td> <td class="priority-low views-field views-field-field-detailed-description-2" headers="view-field-detailed-description-2-table-column">CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug </td> <td headers="view-field-change-date-response-letter-table-column" class="views-field views-field-field-change-date-response-letter"> </td> <td headers="view-field-change-date-closeout-letter-table-column" class="views-field views-field-field-change-date-closeout-letter"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> <tr> <td headers="view-field-change-date-2-table-column" class="views-field views-field-field-change-date-2 is-active"><time datetime="2024-11-12T14:20:00Z">11/12/2024</time> </td> <td headers="view-field-letter-issue-datetime-table-column" class="views-field views-field-field-letter-issue-datetime"><time datetime="2024-11-07T05:00:00Z">11/07/2024</time> </td> <td class="priority-medium views-field views-field-company-name" headers="view-company-name-table-column"><a href="/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zhejiang-qimei-cosmetics-co-ltd-690950-11072024">Zhejiang Qimei Cosmetics Co., Ltd.</a> </td> <td class="priority-low views-field views-field-field-building" headers="view-field-building-table-column">Center for Drug Evaluation and Research (CDER) </td> <td class="priority-low views-field views-field-field-detailed-description-2" headers="view-field-detailed-description-2-table-column">CGMP/Finished Pharmaceuticals/Adulterated </td> <td headers="view-field-change-date-response-letter-table-column" class="views-field views-field-field-change-date-response-letter"> </td> <td headers="view-field-change-date-closeout-letter-table-column" class="views-field views-field-field-change-date-closeout-letter"> </td> <td class="all views-field views-field-search-api-excerpt" headers="view-search-api-excerpt-table-column"> </td> </tr> </tbody> </table> </div> <div class="feed-icons"> <div class="xlsx-feed 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