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Shortly after Valisure reported that it had found benzene in hand sanitizer, the FDA spent several weeks combing through the lab’s facilities and ultimately accused it of operating without ...Valisure, LLC. 5 Science Park, New Haven, CT 06511, 833-825-4787, www.valisure.com . May 24, 2021 . Division of Dockets Management . Food and Drug Administration . 5630 Fishers Lane, Room 1061 . Rockville, MD 20852 . Re: Valisure Citizen Petition on Benzene in Sunscreen and After-sun Care Products . Dear Sir or Madam:Valisure petitioned the FDA for recalls on dry shampoos after research in an independent lab found that nearly 70% of samples tested had concerning levels of a cancer-causing chemical, benzene. November 04, 2022 - Last month, Unilever North America voluntarily recalled multiple dry shampoo products, citing the presence of benzene in the ...Valisure’s November 1, 2022, Citizen Petition on benzene contamination in dry shampoo was announced exclusively via Bloomberg in an article titled, " Cancer-Causing Toxin Found in Dry Shampoos Still on Store Shelves, Study Shows. " National healthcare reporter Anna Edney tells the story of how Valisure tested 148 batches from 34 brands of dry ...Benzene is not an ingredient intentionally used in sunscreens, but the products on Valisure's list were found to be contaminated with benzene."Benzene is a chemical that, when activated with exposure to the skin, blood, or organs, can affect changes in your DNA that cause mutations for cancers," says Madhuri Chadha, M.D., founder of Dr. Madh Skin Solutions and radiologist currently working in ...Valisure investigated further mechanisms relevant to the conditions in the human body and identified a broadly expressed enzyme, DDAH-1, which is known to cleave DMA from its substrate and release it, presenting a known risk of NDMA formation. 4 Valisure’s computational modelling suggest this enzymeOn May 25, 2021, Valisure announced our detection of high levels of benzene, a known human carcinogen, in several brands and batches of sunscreen, which are considered drug products by the Food and Drug Administration (FDA), as well as in after-sun care products, which FDA generally regulates as cosmetics. Valisure analyzed 294 unique batches ... In the laboratory test conducted by Valisure, 294 unique batches of sun care products from 69 different companies were examined. Results of the test found 27% of samples tested contained detectable benzene, while some batches contained up to 3 times the FDA concentration limit of 2 parts per million (ppm).Nov 4, 2022 · Valisure petitioned the FDA for recalls on dry shampoos after research in an independent lab found that nearly 70% of samples tested had concerning levels of a cancer-causing chemical, benzene. November 04, 2022 - Last month, Unilever North America voluntarily recalled multiple dry shampoo products, citing the presence of benzene in the ... Valisure's novel approach to independent quality assurance has had a tremendous global impact and built a foundation of thought leadership that increasingly influences academia, government, and ...At Valisure, we are often asked how to safely dispose of products with suspected or known contamination, like benzene. Given benzene’s potential threat to human health and the natural environment, there are many disposal precautions for benzene-containing items, and these regulations concerning benzene disposal vary by state. Connecticut ... Valisure CEO Testimony at Senate Finance Committee on the FDA’s Foreign Drug Manufacturing Inspection Process April 26, 2022 U.S. Senator Richard Blumenthal’s Reaction to Benzene in Sunscreens Mar 31, 2022 · Shortly after Valisure reported that it had found benzene in hand sanitizer, the FDA spent several weeks combing through the lab’s facilities and ultimately accused it of operating without ... In early November, Valisure issued a citizen petition to the FDA stating that its testing revealed benzene was present at up to nine times the emergency FDA limit of 2 parts per million in several ...Valisure is the first online Analytical Pharmacy to chemically batch-validate medications and is committed to ensuring the safety, quality and consistency of the medications it delivers to consumers.Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ...Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ...In 2021, Valisure sold its pharmacy subsidiary to a pharmacy chain and continued to work with pharmacies and other stakeholders throughout the healthcare industry to incorporate the benefits of independent quality assurance. Valisure’s November 1, 2022, Citizen Petition on benzene contamination in dry shampoo builds upon the growing list of ...Valisure is registered with the Drug Enforcement Administration (License # RV0484814). Valisure’s mission is to help ensure the safety, quality and consistency of medications and supplements in the market. In response to rising concerns about counterfeit medications, generics, and overseas manufacturing, Valisure developed proprietary analyticalIn early November, Valisure issued a citizen petition to the FDA stating that its testing revealed benzene was present at up to nine times the emergency FDA limit of 2 parts per million in several ...Jun 6, 2023 · Valisure Named Honorable Mention in Category of Fast Company’s 2022 World Changing Ideas Awards April 20, 2022 David Light Awarded Junior Achievement's Entrepreneur of The Year Award The notorious drug testing company Valisure, which has made a name for itself by forcing FDA's hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered ...Then on Monday, Valisure sent a citizen petition to the US Food and Drug Administration in which the lab described that among 148 batches from 34 different brands of dry shampoo products, 70% of ...Oct 24, 2022 · Valisure, a pharmacy that batch tests medication before it reaches consumers, tested 294 different batches of sun care products from 69 different companies (find the full results here, on page 12). Dec 7, 2022 · In a Dec. 5 letter, the agency wrote Valisure that its online pharmacy failed to take several basic steps to ensure that suspect or illegitimate medicines were investigated and that distributors ... Valisure Signs Agreement With Department Of Defense To Independently Test & Quality Score Drugs Valisure and DoD Signed a Cooperative Research & Development Agreement to Conduct a Pharmaceutical Quality Risk Assessment Pilot StudyValisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ...Here's a list of brands, manufacturers and sunscreens with benzene, according to Valisure: Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Lotion, SPF 50 Babyganics Kid's Sunscreen ...Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ... Valisure, a New Haven, Connecticut-based analytical laboratory, tested 148 batches from 34 brands of spray-on dry shampoo and found that 70% contained benzene. The chemical can cause certain blood ...Jan 10, 2020 · A car on a hot summer day could reach 140 F.) Valisure reported the results to the FDA, which took exception to the testing methods, saying that its testing at lower temperatures had resulted in ... March 24, 2021. On March 24th, 2021, Valisure announced our detection of high levels of benzene, a known human carcinogen, in several brands and batches across multiple brands of hand sanitizer, which are considered drug products regulated by the Food and Drug Administration (FDA). Benzene is known to cause cancer in humans according to the U.S ...Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ... Valisure And Govzilla Announce A Collaboration Focused On Creating A Platform For Evidence-Based Quality Scores For Drug Products. September 13, 2019-Valisure.Ranitidine molecule. “Beyond Valisure’s tests, the presence of NDMA in ranitidine is supported by decades of scientific studies at institutions around the world starting as early as 1982. The data published today adds to a growing body of research that raises serious concern regarding ranitidine and its potential to form the potent ... Nov 4, 2021 · NEW HAVEN, CT – NOVEMBER 4, 2021 – Valisure LLC has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of antiperspirant body sprays, which are considered drug products by the Food and Drug Administration (FDA), as well as in deodorant body spray products, which FDA generally regulates as ... On March 2, 2020, Valisure announced its detection of N-Nitrosodimethylamine (NDMA) in specific lots of the drug metformin, a prescription medication used to control high blood sugar in adults and adolescents with type 2 diabetes. Of the 22 companies selling metformin and a total of 38 batches revealed 16 batches and 11 companies where NDMA ... NEW HAVEN, CT – MAY 25, 2021 – Valisure LLC has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of sunscreen, which are considered drug products by the Food and Drug Administration (FDA), as well as in after-sun care products, which are generally regulated by FDA as cosmetics.The FDA has said the risk for anyone exposed to nitrosamines in drugs is small. The agency has set acceptable limits on six types of nitrosamines, which equal up to one case of cancer per 100,000 ...On May 24, 2021, Valisure released its findings showing cancer-causing chemicals in sunscreens. Two days later, two FDA inspectors showed up at the lab, according to agency documents. They brought ...Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ... Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ...Aug 8, 2023 · Valisure's novel approach to independent quality assurance has had a tremendous global impact and built a foundation of thought leadership that increasingly influences academia, government, and ... Jun 6, 2023 · Valisure Named Honorable Mention in Category of Fast Company’s 2022 World Changing Ideas Awards April 20, 2022 David Light Awarded Junior Achievement's Entrepreneur of The Year Award Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ... Valisure Named Honorable Mention in Category of Fast Company’s 2022 World Changing Ideas Awards April 20, 2022 David Light Awarded Junior Achievement's Entrepreneur of The Year AwardSarah D. Young, Reporter and Editor. • Mar 30, 2021. Some hand sanitizers have elevated levels of the human carcinogen Benzene, according to a new study conducted by Valisure, an independent ...On March 2, 2020, Valisure announced its detection of N-Nitrosodimethylamine (NDMA) in specific lots of the drug metformin, a prescription medication used to control high blood sugar in adults and adolescents with type 2 diabetes. Of the 22 companies selling metformin and a total of 38 batches revealed 16 batches and 11 companies where NDMA ...Valisure notes that many dry shampoo products tested had no detectable level of benzene, so it appears that such products can adhere to strict limits. N-nitrosamines. Valisure detected N-Nitrosamines like “NDMA” in multiple drug products, which were followed by broad recalls of ranitidine (Zantac), metformin, and other drugs. Although the ...Description. Developer of laser-induced quantum shift emissions-based technology designed to address the variability and quality problems that pervade many pharmaceutical products throughout the United States. The company's technology focuses on patient advocacy, consumer protection, and performing advanced research and development that is ...Dec 7, 2022 · In a Dec. 5 letter, the agency wrote Valisure that its online pharmacy failed to take several basic steps to ensure that suspect or illegitimate medicines were investigated and that distributors ... Valisure, LLC, New Haven FEI3012063246 page2 Section 582(c)(4) and (d)(4) of the FD&C Act establishes the DSCSA’s verification requirements for wholesale distributors and dispensers respectively ... Feb 16, 2023 · Images: Reuters/AFP/Getty Images Composite: Mark Kelly. Claims by the small laboratory company, Valisure LLC, that popular consumer products contain cancer-causing chemicals have generated ... Mar 24, 2021 · NEW HAVEN, CT – MARCH 24, 2021 – Valisure has tested and detected benzene, a known human carcinogen, in several batches across multiple brands of hand sanitizer, which are considered drug products regulated by the Food and Drug Administration (FDA). Valisure is a partner for quality that is paving the way for increased transparency and quality assurance throughout the healthcare industry. Our novel approach to independent quality assurance has an immense global impact that drives revisiting and improving the pharma and consumer products ecosystem. Given the substantial and alarming concerns within the healthcare ecosystem, Valisure is ... Valisure’s hand sanitizer analysis found the highest levels of benzene in small brands that popped up as demand for the product spiked. Out of 260 samples from 168 brands sold on Amazon, at ...Valisure CEO Testimony at Senate Finance Committee on the FDA’s Foreign Drug Manufacturing Inspection Process April 26, 2022 U.S. Senator Richard Blumenthal’s Reaction to Benzene in SunscreensAt Valisure, we are often asked how to safely dispose of products with suspected or known contamination, like benzene. Given benzene’s potential threat to human health and the natural environment, there are many disposal precautions for benzene-containing items, and these regulations concerning benzene disposal vary by state. Connecticut ...A car on a hot summer day could reach 140 F.) Valisure reported the results to the FDA, which took exception to the testing methods, saying that its testing at lower temperatures had resulted in ...Valisure investigated further mechanisms relevant to the conditions in the human body and identified a broadly expressed enzyme, DDAH-1, which is known to cleave DMA from its substrate and release it, presenting a known risk of NDMA formation. 4 Valisure’s computational modelling suggest this enzymeValisure is an independent laboratory and partner for quality that provides increased transparency and quality assurance throughout the healthcare industry.Valisure first gained national attention in September 2019, when its finding led to the discovery that all versions of the heartburn drug Zantac contained levels of the cancer-causing chemical N ...Valisure, a New Haven, Connecticut-based analytical laboratory, tested 148 batches from 34 brands of spray-on dry shampoo and found that 70% contained benzene. The chemical can cause certain blood ...On May 24, 2021, Valisure released its findings showing cancer-causing chemicals in sunscreens. Two days later, two FDA inspectors showed up at the lab, according to agency documents. They brought ...Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more.Nov 30, 2021 · In early November, Valisure issued a citizen petition to the FDA stating that its testing revealed benzene was present at up to nine times the emergency FDA limit of 2 parts per million in several ... The notorious drug testing company Valisure, which has made a name for itself by forcing FDA's hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered ...Mar 18, 2022 · Valisure’s hand sanitizer analysis found the highest levels of benzene in small brands that popped up as demand for the product spiked. Out of 260 samples from 168 brands sold on Amazon, at ... Mar 31, 2022 · Shortly after Valisure reported that it had found benzene in hand sanitizer, the FDA spent several weeks combing through the lab’s facilities and ultimately accused it of operating without ... To better determine the scope of contamination, Valisure continued to analyze sunscreen and after-sun care products through a crowdsourced study that allowed for broader product sampling and facilitated access to sun care products that were sold before lab sourcing efforts. Read the complete study here. Oct 24, 2022 · Valisure, a pharmacy that batch tests medication before it reaches consumers, tested 294 different batches of sun care products from 69 different companies (find the full results here, on page 12). Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ... Jun 6, 2023 · Valisure Named Honorable Mention in Category of Fast Company’s 2022 World Changing Ideas Awards April 20, 2022 David Light Awarded Junior Achievement's Entrepreneur of The Year Award Nov 4, 2022 · Then on Monday, Valisure sent a citizen petition to the US Food and Drug Administration in which the lab described that among 148 batches from 34 different brands of dry shampoo products, 70% of ... NEW HAVEN, CT – NOVEMBER 4, 2021 – Valisure LLC has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of antiperspirant body sprays, which are considered drug products by the Food and Drug Administration (FDA), as well as in deodorant body spray products, which FDA generally regulates as ...Dec 9, 2022 · The notorious drug testing company Valisure, which has made a name for itself by forcing FDA's hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered ... The FDA has said the risk for anyone exposed to nitrosamines in drugs is small. The agency has set acceptable limits on six types of nitrosamines, which equal up to one case of cancer per 100,000 ...Valisure has entered into a Cooperative Research and Development Agreement (CRADA) with the Department of Defense (DoD) in order to generate objective drug quality data through independent sourcing and chemical testing. Below is a brief overview, background and overarching objective of this pharmaceutical quality risk assessment pilot study ... NEW HAVEN, CT – MARCH 24, 2021 – Valisure has tested and detected benzene, a known human carcinogen, in several batches across multiple brands of hand sanitizer, which are considered drug products regulated by the Food and Drug Administration (FDA).Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ... March 24, 2021. On March 24th, 2021, Valisure announced our detection of high levels of benzene, a known human carcinogen, in several brands and batches across multiple brands of hand sanitizer, which are considered drug products regulated by the Food and Drug Administration (FDA). Benzene is known to cause cancer in humans according to the U.S ... Valisure Signs Agreement With Department Of Defense To Independently Test & Quality Score Drugs Valisure and DoD Signed a Cooperative Research & Development Agreement to Conduct a Pharmaceutical Quality Risk Assessment Pilot StudyValisure is urging the FDA to recall the above products and created a petition to support its efforts. And while one might think that a recall is a no-brainer, things are a bit muddled because the ...For Valisure’s scientists, finding NDMA in ranitidine was a particularly dramatic example of the kind of discovery they make routinely. Valisure checks the chemical makeup of drugs before it ...A car on a hot summer day could reach 140 F.) Valisure reported the results to the FDA, which took exception to the testing methods, saying that its testing at lower temperatures had resulted in ...Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ... Send us a message. Thank you for your interest in Valisure. Please know that we read all the messages sent to us. However, you may not get a personal reply due to the large volume of messages we receive.Oct 24, 2022 · Valisure, a pharmacy that batch tests medication before it reaches consumers, tested 294 different batches of sun care products from 69 different companies (find the full results here, on page 12). Then on Monday, Valisure sent a citizen petition to the US Food and Drug Administration in which the lab described that among 148 batches from 34 different brands of dry shampoo products, 70% of ...NEW HAVEN, CT – MAY 25, 2021 – Valisure LLC has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of sunscreen, which are considered drug products by the Food and Drug Administration (FDA), as well as in after-sun care products, which are generally regulated by FDA as cosmetics.Valisure is an independent laboratory and partner for quality that provides increased transparency and quality assurance throughout the healthcare industry. In response to rising concerns and ...

To better determine the scope of contamination, Valisure continued to analyze sunscreen and after-sun care products through a crowdsourced study that allowed for broader product sampling and facilitated access to sun care products that were sold before lab sourcing efforts. Read the complete study here.. Ms annie

Valisure, LLC. 5 Science Park, New Haven, CT 06511, 833-825-4787, www.valisure.com . May 24, 2021 . Division of Dockets Management . Food and Drug Administration . 5630 Fishers Lane, Room 1061 . Rockville, MD 20852 . Re: Valisure Citizen Petition on Benzene in Sunscreen and After-sun Care Products . Dear Sir or Madam:Aug 11, 2021 · Here's a list of brands, manufacturers and sunscreens with benzene, according to Valisure: Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Lotion, SPF 50 Babyganics Kid's Sunscreen ... Valisure notes that many dry shampoo products tested had no detectable level of benzene, so it appears that such products can adhere to strict limits. N-nitrosamines. Valisure detected N-Nitrosamines like “NDMA” in multiple drug products, which were followed by broad recalls of ranitidine (Zantac), metformin, and other drugs. Although the ...Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ... Valisure, LLC, New Haven FEI3012063246 page2 Section 582(c)(4) and (d)(4) of the FD&C Act establishes the DSCSA’s verification requirements for wholesale distributors and dispensers respectively ... Bloomberg’s The Big Take Feature Story: A Tiny Lab Finds Danger on Drugstore Shelves While the FDA Lags Behind. National healthcare reporter, Anna Edney, covers in an in-depth article how in just 3 years, Valisure's quest to hunt down cancer-causing chemicals in everyday products has impacted pharmaceuticals and consumer goods in markets worth an estimated $9 billion that touch the lives of ...At Valisure, we are often asked how to safely dispose of products with suspected or known contamination, like benzene. Given benzene’s potential threat to human health and the natural environment, there are many disposal precautions for benzene-containing items, and these regulations concerning benzene disposal vary by state. Connecticut ...Aug 11, 2021 · Here's a list of brands, manufacturers and sunscreens with benzene, according to Valisure: Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Lotion, SPF 50 Babyganics Kid's Sunscreen ... NEW HAVEN, CT – NOVEMBER 4, 2021 – Valisure LLC has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of antiperspirant body sprays, which are considered drug products by the Food and Drug Administration (FDA), as well as in deodorant body spray products, which FDA generally regulates as ...Concerns about sunscreen safety, many entirely unfounded, continue to bubble up. The latest are stemming from a study by Valisure, an independent, for-profit pharmacy and research testing lab ...Nov 4, 2022 · Valisure petitioned the FDA for recalls on dry shampoos after research in an independent lab found that nearly 70% of samples tested had concerning levels of a cancer-causing chemical, benzene. November 04, 2022 - Last month, Unilever North America voluntarily recalled multiple dry shampoo products, citing the presence of benzene in the ... Tests by Valisure, however, found concerning levels of benzene in some batches of P&G products. The most highly contaminated – two lots of an Old Spice antiperspirant called Pure Sport (Lots ...On March 2, 2020, Valisure announced our detections high levels of N-Nitrosodimethylamine (NDMA) in specific lots of the drug metformin, a prescription medication used to control high blood sugar in adults and adolescents with type 2 diabetes. Valisure’s analysis of 22 companies selling metformin and a total of 38 batches revealed 16 batches ... .

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