Product Quality & Safety

Product Quality & Safety

Patient safety is our highest priority. We are dedicated to developing and delivering safe and effective pharmaceutical products and medical devices that meet the needs of patients and healthcare professionals. Our comprehensive quality management system governs all aspects of drug and device manufacturing providing the foundation for safety that underpins our entire business.

We adhere to strict regulatory requirements, following Good Clinical, Pharmacovigilance, Laboratory, and Manufacturing (GxP) principles throughout our global operations and maintain certifications in numerous international standards to ensure that all our products are manufactured, tested and distributed according to the highest quality standards.

Quality Guiding Principles

We commit to producing the highest quality products, guided by the following principles:

• Patient safety is our highest priority and is at the forefront of every decision we make.
• Complying with applicable laws and regulations, as well as internal requirements, to position our Company as a model for compliance and integrity.
• Providing quality products and services, which meet or exceed the requirements and needs of the patients and customers we serve.
• Continuously improving our quality systems, processes and operational excellence through analysis and benchmarking against current regulatory expectations and requirements.
• Encouraging participation and promotion of quality responsibilities among all employees through education, training, coaching, and effective communication.

We communicate our position on product quality to all employees, providing the required leadership, management, and resources to achieve our quality objectives.

Patient Safety

Patient safety lies at the heart of our mission. We are dedicated to ensuring the safety and efficacy of our products throughout their lifecycle. Our global pharmacovigilance system is the cornerstone of our commitment - monitoring the safety of our products from clinical trials to post-market surveillance. Mallinckrodt mandates annual training for employees and contractors in pharmacovigilance and adverse event reporting, ensuring prompt and accurate handling of safety information.

Global Pharmacovigilance 

You may contact Global Pharmacovigilance to report any side effect / adverse drug experience related to a medicinal product. Full details on contacting Pharmacovigilance can be found here.

Product Monitoring

You may contact Product Monitoring to report any quality complaint or medical device report. Full details on contacting Product Monitoring globally can be found here.

Environmental, Health & Safety (EHS)

Mallinckrodt is also dedicated to ensuring the health and safety of our employees, stakeholders and communities. Our commitment to maintaining high standards in health and safety permeates every aspect of our operations and is reflected in Mallinckrodt’s global Environmental, Health and Safety (EHS) policy that applies to all employees and contractors. Practices that help us build our culture of safety include:

• Enterprise EHS Management System: Our comprehensive Enterprise EHS Management System serves as the cornerstone of our safety culture, providing a structured framework for identifying, assessing, and managing risks.
• Occupational Health and Safety Policies and Procedures: Aligned with our EHS Management System, we maintain rigorous occupational health and safety policies and procedures designed to mitigate workplace hazards, prevent accidents and promote a culture of safety excellence.
• Training and Education: We have comprehensive training programs that equip our employees and contractors with the knowledge and skills necessary to identify risks and implement safety measures effectively.
• Health Promotion: We prioritize the physical and mental well-being of our employees by offering various health promotion initiatives, including wellness programs, access to healthcare services, and resources for stress management and mental health support through our Employee Assistance Program.

To access our Safety Data Sheets (SDS), please use our SDS search database.

Read more about our progress in our 2023 Sustainability Report.