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		<meta data-vue-meta="ssr" property="og:title" content="Bausch + Lomb Receives FDA Warning Letter for Tampa, Florida, Plant, Citing Persistent Contamination | Market Scope" data-vmid="og:title"><meta data-vue-meta="ssr" property="og:description" content="The US FDA sent Bausch + Lomb a warning letter Sept. 4 regarding significant violations observed at its manufacturing plant in Tampa, Florida, during an FDA inspection in March 2026. The Tampa location is the company’s only pharmaceutical plant in the US, according to Workforce Development Partners, which interviewed Bausch + Lomb officials about the facility in 2022. The site manufactures prescription and over-the-counter ophthalmic medications distributed to more than 40 countries around th..." data-vmid="og:description"><meta data-vue-meta="ssr" property="og:url" content="//www.market-scope.com/pages/news/9413/bausch-and-lomb-receives-fda-warning-letter-for-tampa-florida-plant-citing-persistent-contamination" data-vmid="og:url"><meta data-vue-meta="ssr" property="og:type" content="article" data-vmid="og:type"><meta data-vue-meta="ssr" property="article:published_time" content="2026-09-25T00:00:00.000Z" data-vmid="article:published_time"><meta data-vue-meta="ssr" name="image" property="og:image" content="https://www.market-scope.com/files/uploads/images/2024/05/LinkedIn%202024%20FDA%20Ophthalmic%20News.jpg" data-vmid="og:image"><meta data-vue-meta="ssr" name="author" content="Joan McKenna" data-vmid="author"><meta data-vue-meta="ssr" name="description" content="The US FDA sent Bausch + Lomb a warning letter Sept. 4 regarding significant violations observed at its manufacturing plant in Tampa, Florida, during an FDA ..." data-vmid="description">
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All Rights reserved.</p></footer></div> <!----> <!----> <!----></div> <div id="invisible-recaptcha" data-sitekey="6LcfrXEUAAAAAL8oovQG9EMVvWYIrcgcHP2eWtjb" class="g-recaptcha g-recaptcha--left g-recaptcha--mobile-hidden g-recaptcha--desktop-hidden"></div> <!----></div><script>window.__INITIAL_STATE__={"companyNames":[],"articles":[],"article":{"id":9413,"position":23,"enabled":1,"draft":0,"author_uid":332,"author_custom":"","title":"Bausch + Lomb Receives FDA Warning Letter for Tampa, Florida, Plant, Citing Persistent Contamination","slug_auto":"bausch-and-lomb-receives-fda-warning-letter-for-tampa-florida-plant-citing-persistent-contamination","slug_override":null,"slug_history":null,"meta_title":null,"content":"\u003Chtml\u003E\u003Cbody\u003E\u003Cp style=\"text-align:center\"\u003E\u003Cimg alt=\"Bausch + Lomb Receives FDA Warning Letter for Tampa, Florida, Plant, Citing Persistent Contamination\" height=\"287\" src=\"\u002Ffiles\u002Fuploads\u002Fimages\u002F2024\u002F05\u002FLinkedIn%202024%20FDA%20Ophthalmic%20News.jpg\" width=\"550\" class=\"img-thumbnail \"\u003E\u003C\u002Fp\u003E\r\n\r\n\u003Cp\u003EThe US FDA sent Bausch + Lomb a \u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fbausch-lomb-inc-732398-09042026\" target=\"_blank\"\u003Ewarning letter\u003C\u002Fa\u003E Sept. 4 regarding significant violations observed at its manufacturing plant in Tampa, Florida, during an FDA \u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F193813\u002Fdownload\" target=\"_blank\"\u003Einspection\u003C\u002Fa\u003E in March 2026.\u003C\u002Fp\u003E\r\n\r\n\u003Cp\u003EThe Tampa location is the company&rsquo;s only pharmaceutical plant in the US, according to Workforce Development Partners, which interviewed Bausch + Lomb officials about the facility in 2022.\u003C\u002Fp\u003E\r\n\r\n\u003Cp\u003EThe site manufactures prescription and over-the-counter ophthalmic medications distributed to more than 40 countries around the world.\u003C\u002Fp\u003E\r\n\r\n\u003Cp\u003EBausch + Lomb&rsquo;s pharmaceuticals division generated revenue of $1.3 billion in 2025, accounting for a quarter of the company&rsquo;s total $5.1 billion for the year.\u003C\u002Fp\u003E\r\n\r\n\u003Cp\u003EThe FDA warning letter took issue with persistent contamination in cleanroom environments.\u003C\u002Fp\u003E\r\n\r\n\u003Cp\u003EConcerns included that microorganisms recovered from the facility, including \u003Cem\u003EPseudomonas aeruginosa\u003C\u002Fem\u003E and \u003Cem\u003EAspergillus brasiliensis\u003C\u002Fem\u003E, were the same genus and species as those recovered from several consumer complaint samples.\u003C\u002Fp\u003E\r\n\r\n\u003Cp\u003EThe letter noted that basic design deficiencies and excessive recoveries of microorganisms from ISO 5 areas indicated that there was significant inherent contamination risk in the current operation.\u003C\u002Fp\u003E\r\n\r\n\u003Cp\u003EThe FDA said it was not satisfied with Bausch + Lomb&rsquo;s initial response in April to the findings.\u003C\u002Fp\u003E\r\n\r\n\u003Cp\u003EThe agency told the company to promptly address the violations, yet it also asked to be notified if actions under consideration were likely to lead to a disruption in the supply of drugs produced at the facility.\u003C\u002Fp\u003E\r\n\u003C\u002Fbody\u003E\u003C\u002Fhtml\u003E\n","content_hub":null,"content_img_sources":["\u002Ffiles\u002Fuploads\u002Fimages\u002F2024\u002F05\u002FLinkedIn%202024%20FDA%20Ophthalmic%20News.jpg"],"share_img_filename":null,"preview_img_blurhash":"LDAnyT-;NLM|4-Iqoys7~V-oocM|","preview_img_width":1200,"preview_img_height":627,"meta_description":null,"allowed_roles":"24","inherit_specialty_descendents":1,"rules":[],"publish_date":"2026-09-25","qdrant_id":null,"entities":[{"text":"Tampa, Florida","type":"location"},{"text":"Workforce 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