Latest news with #CurrentGoodManufacturingPractices
Time of India
15-05-2025
- Health
- Time of India
FDA recalls nearly 76,000 eye care products over major safety concerns: full list inside
In a shocking development, The U.S. Food and Drug Administration (FDA) has issued an urgent recall of nearly 76,000 cases of eye care products due to serious safety concerns. This in essence, affects many popular eye drops and artificial tears that were found to have manufacturing issues, potentially putting users at risk. If you use eye drops or artificial tears, it's important to check if your product is on the list. Let's find out more... The reason behind the recall The recall followed an FDA audit, that revealed significant deviations from Current Good Manufacturing Practices (cGMP) at the manufacturing facility of BRS Analytical Service, LLC. These deviations mean that the products fall short of the required safety standards. Not only that, the FDA found a lack of assurance of sterility, which means the products might be contaminated and unsafe for use in the eyes. The list also included drops for dry eyes, as the FDA found 'lack of assurance of sterility" in the products. While the exact health risks from using these products is still being studied, the FDA classified this recall as Class II. This means that using these products could cause many health issues, and although serious harm is unlikely, the risk cannot be overlooked. List of Recalled Eye Care Products The recall covers five different ophthalmic solutions distributed nationwide between May 26, 2023, and April 21, 2025. The products have expiration dates ranging from April 2025 to March 2027. Here is the list of affected items: NDC #50268-043-15 Artificial Tears Ophthalmic Solution NDC #50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1% NDC #50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution NDC #50268-126-15 Lubricant Eye Drops Solution NDC #50268-678-15 Polyvinyl Alcohol Ophthalmic Solution What should users do? Stop using the product immediately Check the lot number and expiration date on your product against the recall list available on AvKare's (a medical firm that first notified the recall) website or the FDA recall notice. Once identified, return the product to AvKare for a full refund. To do this, you need to fill out a return form available on AvKare's website, and send it to receive a Return Authorization Form. Consult your eye doctor if you experience any irritation, redness, pain, or vision problems after using the recalled products. Where Were These Products Sold? The recalled products were distributed across the United States through retail outlets, pharmacies, and online stores. Exact names of stores was no disclosed. Why is sterility important in eye products Eye drops and artificial tears must be sterile because the eyes are extremely sensitive and vulnerable to infections. Contaminated eye products can cause serious eye infections, irritation, or even damage to vision, which can also be permanent and irreversible. One step to a healthier you—join Times Health+ Yoga and feel the change
Business Upturn
12-05-2025
- Business
- Business Upturn
Wanbury's Tanuku facility in Andhra Pradesh completes ANVISA inspection with zero observations
Wanbury Limited announced the successful completion of an inspection by the Brazilian Health Regulatory Agency (ANVISA) at its manufacturing facility in Tanuku, Andhra Pradesh. The inspection was conducted from December 16 to December 20, 2024. According to Wanbury, the inspection concluded with zero observations, indicating full compliance with ANVISA's regulatory standards. The facility was evaluated for adherence to Current Good Manufacturing Practices (cGMP), which are required for pharmaceutical manufacturing. Advertisement Following the inspection, ANVISA granted the Good Manufacturing Practices (GMP) Certificate to the Tanuku facility. The Certificate of Good Manufacturing Practices (Certificado de Boas Práticas de Fabricação – CBPF) has been issued in both English and Portuguese. This certification is necessary for the export of pharmaceutical products to Brazil and demonstrates the facility's compliance with Brazilian regulatory requirements.
Yahoo
17-04-2025
- Business
- Yahoo
Thermo Fisher Scientific Opens Advanced Therapies Collaboration Center in Greater San Diego to Help Accelerate Cell Therapy Development
Innovative 6,000-square-foot facility enables clinical and commercial process development support to help cell therapy developers transition from research-scale to commercialization CARLSBAD, Calif., April 17, 2025--(BUSINESS WIRE)--Thermo Fisher Scientific Inc., the world leader in serving science, today announced the grand opening of its Advanced Therapies Collaboration Center (ATxCC) in Carlsbad, Calif. This advanced facility is designed to accelerate the development and commercialization of cell therapies, specifically by supporting biotech, biopharma and translational customers developing cell-based immunotherapies. Through this new center, cell therapy developers can leverage Thermo Fisher's expansive product and technology portfolio and deep process optimization knowledge to create comprehensive, end-to-end manufacturing workflows that can scale to enable clinical and commercial success. This initiative is part of Thermo Fisher's commitment to advancing life sciences and improving patient outcomes through innovative solutions. "Our new Advanced Therapies Collaboration Center represents a significant milestone in our ongoing commitment to deliver solutions that address critical challenges in cell therapy development. By enabling access to our expertise and broad range of instrumentation, reagents, lab equipment and analytical solutions, we aim to help our customers overcome manufacturing hurdles and accelerate their path to commercialization," said Betty Woo, vice president, cell, gene and advanced therapies, Thermo Fisher Scientific. "By fostering collaboration and innovation, the center is poised to play a pivotal role in helping to advance cell therapies, ultimately improving patient lives." Partnering closely with Thermo Fisher, cell therapy developers can receive the essential resources and support they need to transition to Current Good Manufacturing Practices (cGMP manufacturing). This collaboration helps navigate go-to-market obstacles. Key ATxCC program benefits include: Access to innovative technologies: Developers gain access to Thermo Fisher laboratory equipment and analytical solutions – even before these technologies are available to the broader market. These advanced technologies can streamline manufacturing, help limit contamination risks and promote product consistency. Protocol and process optimization support: Specialized scientists and engineers facilitate support in creating optimized manufacturing processes and protocols utilizing Thermo Fisher products, helping ensure they are scalable and robust. Ongoing support as therapeutic programs evolve: Dedicated regulatory, quality and partnership management teams assist developers in growing and advancing their cell therapy programs by addressing new challenges and enabling platform-specific support. With collaboration centers already established in Singapore and Korea, Thermo Fisher is thrilled to announce the opening of our Carlsbad center, with an expanded footprint in Philadelphia expected later this year. Both centers are designed to offer clinical and commercial cGMP process development to our valued partners. For more information about Thermo Fisher's advanced therapies collaboration center program, please visit About Thermo Fisher ScientificThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit View source version on Contacts Media Contact Information:Name: Dana MaxwellPhone: (760) 859-8539E-mail: Sign in to access your portfolio
Yahoo
03-04-2025
- Business
- Yahoo
Lief Labs Launches 2025 Brand Boost Guide for Nutritional Supplement Brands
Lief's 2025 guide offers supplement industry insider tips for brand enhancement and growth VALENCIA, CA / / April 3, 2025 / Lief Labs, a premier formulation and product development innovator and manufacturer of dietary supplements, is pleased to announce the launch of its complimentary 2025 Brand Boost Guide which offers tips, guidance and resources to support dietary supplement brands in identifying potential sales growth and risk management strategies. Among the key areas of guidance in Lief's 2025 Brand Boost Guide include strategic evaluation of product lines, brand mission statements, formulation considerations and supply chain management. "Lief has always strived to elevate our brand relationships to not only support them with their contract manufacturing needs, but to also offer counsel as a collaborative partner with a vested interest in providing critical market insights to help our brand partners continually drive innovation and growth in an evolving economic landscape and marketplace," said Thomas Luna, Chief Operations Officer of Lief Labs. "We hope the tips and strategies offered in Lief's 2025 Brand Boost Guide will be a valuable resource of best practices and strategic enhancements that can reinvigorate brands to be better positioned for success moving forward." Lief Labs' 2025 Brand Boost Guide Lief's complimentary Brand Boost Guide is available to all brands in the supplement industry who are looking for guidance as they develop business strategies. Supplement brands are also encouraged to speak with Lief experts for further discussion of the Brand Boost Guide to determine which strategies may fit best based on their individual brand needs and resources. For brands interested in obtaining Lief's 2025 Brand Boost Guide, visit to download your complimentary guide, or for additional information please contact info@ About Lief Labs Lief Labs is a premier formulation and product development innovator and manufacturer of dietary supplements. Our in-house Product Development and R&D team creates the best tasting and most cutting-edge formulations of supplements. Lief also houses over 220,000 sq ft of new and fully renovated, full-service, state-of-the-art, Current Good Manufacturing Practices (cGMP) manufacturing facility, which includes an in-house analytical testing lab and a microbiology lab, and offers custom solutions for a multitude of supplement categories. Lief collaborates with entrepreneurial firms to help them build premier brands. Our turnkey solutions allow us to engage in seamless partnerships that help brands with scalability and sustainable growth. Lief hosts the Beyond the Supps podcast which covers a wide range of topics such as entrepreneurship, social media, quality control, health & wellness, and the impact the dietary supplement industry has worldwide. The company is based in Valencia, CA. To learn more, please visit For Media Inquiries, please contact: Cathy LoosLoos & Co. Communications+1-347-334-4135cloos@ SOURCE: Lief Labs View the original press release on ACCESS Newswire Sign in to access your portfolio
Associated Press
10-03-2025
- Business
- Associated Press
Emergent BioSolutions Announces Sale of Baltimore-Bayview Manufacturing Site to Syngene International
GAITHERSBURG, Md., March 10, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has entered into an agreement to sell its Baltimore-Bayview drug substance manufacturing facility to Syngene International, a leading global contract research, development, and manufacturing organization, for a total value of $36.5 million. The Bayview site includes manufacturing, laboratory, warehousing and office space, and is fitted with multiple monoclonal antibody (mAbs) manufacturing lines. As part of the agreement, Emergent will retain the rights to secure manufacturing services and capacity at the facility for future growth and pandemic response production in collaboration with Syngene. Emergent continues to operate a streamlined manufacturing network, including facilities in Lansing, Michigan and Winnipeg, Manitoba, Canada capable of serving strategic partners and supporting large-scale projects. 'The sale of Bayview represents a continuation of our efforts to deliver on our multi-year transformation plan and creates a streamlined, customer-focused, leaner, more flexible organization that provides the capabilities to deliver our product demand today and into the future,' said Joe Papa, president and CEO of Emergent. 'Now in our turnaround phase, we see significant opportunities for Emergent's core products and future growth drivers that have the potential to protect and save countless lives.' In March 2024, Emergent received a favorable inspection outcome, 'No Action Indicated' or NAI status classification from the U.S. Food and Drug Administration (FDA) for the Bayview site. Emergent remains committed to ensuring continued compliance with Current Good Manufacturing Practices (CGMP) requirements and delivering high-quality products for communities around the world. Papa added, 'Thanks to the hard work and dedication of colleagues across Emergent, we have strengthened operational quality and compliance systems across our network to continue to uphold the highest standards of patient safety, quality, and compliance in our work every day.' The agreement with Syngene International includes a transfer of assets and equipment associated with the Baltimore-Bayview facility. The sale is expected to close in the first quarter of 2025, subject to the satisfaction of customary closing conditions. For Emergent, Truist served as financial advisor, and Covington & Burling LLP served as legal counsel in connection with this transaction. About Emergent BioSolutions At Emergent, our mission is to protect and save lives. For over 25 years, we've been at work preparing those entrusted with protecting public health. We deliver protective and life-saving solutions for health threats like smallpox, mpox, botulism, Ebola, anthrax and opioid overdose emergencies. To learn more about how we help prepare communities around the world for today's health challenges and tomorrow's threats, visit our website and follow us on LinkedIn, X, Instagram, Apple Podcasts and Spotify. Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements regarding the expected timing for completion of the disposition of Emergent's Baltimore-Bayview facility, Emergent's ability to achieve the objectives of the disposition, including achieving improvement in cost structure and performance, and Emergent's future results, are forward-looking statements. We generally identify forward-looking statements by using words like 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'forecast,' 'future,' 'goal,' 'improve,' 'intend,' 'may,' 'plan,' 'position,' 'possible,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would,' and similar expressions or variations thereof, or the negative thereof, but these terms are not the exclusive means of identifying such statements. Forward-looking statements are based on our current intentions, beliefs and expectations regarding future events based on information that is currently available. We cannot guarantee that any forward-looking statements will be accurate. Readers should realize that if underlying assumptions prove inaccurate or if known or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Readers are, therefore, cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake any obligation to update any forward-looking statement to reflect new information, events or circumstances. There are a number of important factors that could cause Emergent's actual results to differ materially from those indicated by any forward-looking statements. Readers should consider this cautionary statement, as well as the risk factors and other disclosures included in our periodic reports filed with the U.S. Securities and Exchange Commission, when evaluating our forward-looking statements. Investor Contact: Richard S. Lindahl Executive Vice President, CFO Media Contact: Assal Hellmer
