{"id":129994,"date":"2026-10-13T18:05:30","date_gmt":"2026-10-13T09:05:30","guid":{"rendered":"https:\/\/japanir.jp\/en\/ir\/7733-20261013-01_wp_disclosure_update\/"},"modified":"2026-10-13T18:05:30","modified_gmt":"2026-10-13T09:05:30","slug":"7733-20261013-01_wp_disclosure_update","status":"publish","type":"ir_release","link":"https:\/\/japanir.jp\/en\/company\/company-7733\/ir\/7733-20261013-01_wp_disclosure_update\/","title":{"rendered":"Notice Regarding Receipt of Warning Letter from the FDA"},"content":{"rendered":"<p>Received a Warning Letter from the FDA. A total of 6 sites are subject. Corrective and preventive actions have been implemented, and a response will be submitted to the FDA within 15 business days. There are no restrictions on product sales, recalls, or sales clearances, and the impact on consolidated results is currently unknown.<\/p>\n","protected":false},"comment_status":"open","ping_status":"closed","template":"","meta":{"Ticker":"","DATE":"","longName":"","company_name_ja":"","fullTimeEmployees":0,"address":"","phone":"","website":"","industry":"","sector":"","regularMarketPrice":0,"financialCurrency":"","marketCap":0,"fiftyTwoWeekLow":0,"fiftyTwoWeekHigh":0,"epsTrailingTwelveMonths":0,"epsForward":0,"bookValue":0,"totalRevenue":0,"OperatingIncome":0,"operatingMargins":0,"NetIncome":0,"profitMargins":0,"ebitda":0,"trailingPE":0,"forwardPE":0,"priceToBook":0,"returnOnEquity":0,"recommendationMean":0,"recommendationKey":"","targetMeanPrice":0,"numberOfAnalystOpinions":0,"analyst_earnings_data":"","dividendRate":0,"dividendYield":0,"payoutRatio":0,"totalEsg":0,"environmentScore":0,"socialScore":0,"governanceScore":0,"title":"","providerPublishTime":"","link":"","longBusinessSummary":"","longBusinessSummary_ja":"","quarterly_revenue":0,"quarterly_net_income":0,"quarterly_operating_profit":0,"enterprise_value":0,"price_fetched_at":"","company_officer_1_name":"","company_officer_1_title":"","company_officer_2_name":"","company_officer_2_title":"","company_officer_3_name":"","company_officer_3_title":"","company_officer_4_name":"","company_officer_4_title":"","company_officer_5_name":"","company_officer_5_title":"","company_officers_update_time":"","get_dividend_history_year1":0,"get_dividend_history_year2":0,"get_dividend_history_year3":0,"get_dividend_history_year4":0,"get_dividend_history_year5":0,"get_dividend_history_year6":0,"get_dividend_history_year7":0,"get_dividend_history_year8":0,"get_dividend_history_year9":0,"get_dividend_history_year10":0,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"jir_stock_code":"7733","jir_company_name":"Olympus Corporation","jir_importance":"\u2605\u2605\u2605\u2606\u2606","jir_publication_date":"2026-10-13","jir_source_link":"https:\/\/japanir.jp\/wp-content\/uploads\/2026\/10\/7733-20261013-01.pdf","jir_short_summary":"Received a Warning Letter from the FDA. A total of 6 sites are subject. Corrective and preventive actions have been implemented, and a response will be submitted to the FDA within 15 business days. There are no restrictions on product sales, recalls, or sales clearances, and the impact on consolidated results is currently unknown.","jir_summary":"### Risks and Response\nDisclosed receipt of a Warning Letter from the FDA. Six sites are subject, and corrective and preventive actions regarding the quality management system and processes have been implemented. Olympus Corporation is working closely with the FDA and plans to submit a response within 15 business days. At this time, the impact on consolidated results is unknown; material developments will be disclosed in a timely manner.\n\n### Business Impact and Future Disclosures\nThis Warning Letter does not restrict product manufacturing, sales, or distribution, nor does it limit requests for recalls or new sales clearances. The company will continue to prioritize patient safety in its response. If there are material developments, they will be disclosed appropriately in accordance with laws and regulations.","jir_financial_highlights":"Net Sales: Unknown (Unknown)\nOperating Income: Unknown (Unknown)\nNet Income Attributable to Owners of Parent: Unknown (Unknown)","jir_category":"","jir_hashtags":"#Olympus, #FDA, #Disclosure, #WarningLetterResponse","jir_key_figures":"Key Figure 1: Unknown (No figures for net sales, profits, etc. are specified in the body)\nKey Figure 2: Unknown\nKey Figure 3: Unknown","jir_meta_title":"Olympus Corporation \u2014 Notice of Receipt of FDA Warning Letter | October 13, 2026","jir_meta_description":"Olympus Corporation has received a Warning Letter from the FDA affecting six sites. Corrective actions have been implemented and a response will be submitted within 15 business days. Financial impact is currently unknown.","jir_og_title":"Olympus Corporation Notice of Receipt of FDA Warning Letter","jir_og_description":"Notice of receipt of an FDA Warning Letter. Corrective actions completed; response to be submitted within 15 business days. Financial impact is undetermined.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":6918,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"disclosure_update","footnotes":""},"sector":[],"importance":[],"class_list":["post-129994","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Notice Regarding Receipt of Warning Letter from the FDA - Japan IR<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/japanir.jp\/en\/company\/company-7733\/ir\/7733-20261013-01_wp_disclosure_update\/\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/japanir.jp\/en\/company\/company-7733\/ir\/7733-20261013-01_wp_disclosure_update\/\",\"url\":\"https:\/\/japanir.jp\/en\/company\/company-7733\/ir\/7733-20261013-01_wp_disclosure_update\/\",\"name\":\"Notice Regarding Receipt of Warning Letter from the FDA - 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