Pharmaceutical Manufacturing

Heart devices linked to injuries, deaths receive FDA’s most serious recall

April 18, 2024 - In a recent announcement, the Food and Drug Administration (FDA) revealed that a pair of heart devices, the HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS), has received the agency's most serious recall classification due to long-term buildup and has been linked to hundreds of injuries and at least 14 deaths. The recall has raised concerns among safety advocates...

Read More


More Articles

Understanding the environmental impact of the pharmaceutical industry

by Alivia Kaylor

The pharmaceutical industry is crucial in improving global health by developing and manufacturing life-saving medications. However, it also has a significant environmental impact that cannot be ignored.   The Pharmaceutical...

Manufacturing complex pharmaceutical products with new technologies

by Veronica Salib

Scientific advancement and increasingly complex pharmaceutical products have reshaped the healthcare industry, providing novel tools and solutions for managing broad conditions, from acute viral infections to chronic diseases to oncology....

Developing Quality Assurance Standards for Biologics, Biosimilars

by Veronica Salib

Biologics and biosimilars are a rapidly growing sector of the biopharmaceutical industry. However, as the field grows, multiple challenges arise in the manufacturing and quality assurance guidelines for biologics and...

Continuous Manufacturing Revolutionizes Pharmaceutical Production

by Alivia Kaylor

In the pharmaceutical sector, continuous manufacturing (CM) has emerged as a transformative technology with the potential to revolutionize the industry. As drugmakers seek to enhance efficiency, reduce costs, and ensure a resilient supply...

Amgen Opens Its Most Advanced Manufacturing Site in Central Ohio

by Alivia Kaylor

On February 26, 2024, Amgen announced it opened its latest manufacturing site in New Albany, Ohio, located in Central Ohio. The recently established facility stands out as a cornerstone in Amgen's...

Advancing Sterility Assurance Through Environmental Monitoring

by Alivia Kaylor

In the pharmaceutical industry, ensuring the safety and efficacy of drugs is of utmost importance. Quality assurance is critical in maintaining high standards for pharmaceutical products, and one essential aspect of quality assurance is...

FDA Announces Kilitch Healthcare India Eyedrop Recall

by Veronica Salib

On November 15, 2023, the United States Food and Drug Administration published a voluntary recall statement from Kilitch Healthcare India Limited for 27 eyedrops distributed across the US through...

26 More Eyedrops Recalled from CVS, Target, Walmart, Rite Aid and More

by Veronica Salib

On October 27, 2023, the United States Food and Drug Administration (FDA) issued a warning to consumers to avoid using 26 over-the-counter eye drops sold under multiple brands, including CVS Health,...

Innovative Tech for Drug Manufacturing: Revolutionizing Pharma

by Alivia Kaylor

The pharmaceutical industry is no stranger to technological innovation. Over the years, it has seen numerous advancements in drug development, manufacturing processes, and quality control. However, in recent years, the pace of innovation...

How Quality Assurance Shapes US Drug Manufacturing

by Alivia Kaylor

The world of pharmaceuticals stands as a cornerstone of modern medicine. Behind every pill, every capsule, and every syringe lies an intricate process of creation, where precision and excellence are non-negotiable. Drug manufacturing is a...

7 Ways to Increase Pharmaceutical Sustainability

by Alivia Kaylor

The pharmaceutical sector is undeniably indispensable in the global landscape of essential medications. However, beneath the surface lies a harsh reality of environmental devastation and unsustainable practices. A 2019 Lancet report paints...

Over 99% of US Hospital Pharmacists Reported Drug Shortages

by Veronica Salib

The American Society of Health-System Pharmacists (ASHP) recently published statistics on ongoing drug shortages in the United States. The organization’s survey of hospital pharmacists revealed...

Understanding the Basics of Pharmaceutical Compounding

by Alivia Kaylor

The healthcare industry relies heavily on pharmaceutical compounding, as it allows for personalized medication solutions to meet the specific requirements of individual patients. By delving into the vital components of pharmaceutical...

Mallinckrodt Shareholders Doubt Company Will Pay $200M Opioid Settlement

by Hayden Schmidt

United Kingdom-based Mallinckrodt is considering repeat bankruptcy as its $200 million opioid payment comes due. A Security and Exchange Commission (SEC) filing from June 5 showed that company...

Strategies for Sustainability in the Global Pharmaceutical Supply Chain

by Alivia Kaylor

The pharmaceutical industry and its global supply chain play a critical role in the healthcare system, but it also significantly impacts the environment. From the extraction of raw materials to the disposal of drugs, the industry's...

US Continues to Increase Its Reliance on Chinese Pharma Supply Chain

by Hayden Schmidt

According to research from the Atlantic Council, pharmaceutical products have become a valuable part of the United States and China’s trading relationship, growing from 0.6% of the total trade to...

How to Properly Dispose of Unused Drugs, Understanding Key Roles

by Veronica Salib

Unused medications pose a significant threat to healthcare, considering the impacts of improper disposal and drug misuse. Over-the-counter (OTC) and prescription medications that are expired or no longer needed by the intended patient...

FDA Domestic and Foreign Oversight Protocols and Violation Responses

by Veronica Salib

The United States Food and Drug Administration (FDA) has been criticized repeatedly for shortcomings and flaws in its oversight protocols. Understanding the current regulations that the FDA follows for assessing drug manufacturing...

FDA Details Manufacturing Conditions That Led to Eye Drop Recall

by Hayden Schmidt

After a series of infections that left several blind, an FDA inspector discovered that the manufacturing facility used to create Global Pharma’s artificial tears failed to follow evidence-based...

Recent Articles