Cormica‘s Laboratory, MET Achieves First-Time FDA Inspection Success
Cormica, as a global leader in comprehensive microbiological, analytical and physical testing services, upholds a commitment to quality across all its world renown laboratories. Our accreditations include Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), ISO 17025, and recognitions from leading regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA), the US Food and Drug Administration (FDA), and the United Kingdom Accreditation Service (UKAS). These certifications validate our dedication to excellence, enabling us to support clients in launching and releasing their products safely and rapidly worldwide.
MET (Medical Engineering Technologies Ltd), a Cormica laboratory, is dedicated to delivering world-class Combination Device, Medical Device and Pharmaceutical testing services. MET’s capabilities include performance, verification, validation, ageing, transit, packaging testing and analytical chemistry with a keen interest in extractables and leachables . By upholding the highest standards of quality and safety, we ensure that products meet rigorous safety and efficacy standards, maintaining their integrity from development through to market release.
We are excited to announce that MET, has successfully passed its first FDA inspection. The inspection, which took place in April, focused on batch release testing after MET was named on a client’s submission. The result of this rigorous examination was NAI (No Actions Indicated), a significant achievement for our team.
"Passing our first FDA inspection with no actions indicated is a testament to the hard work and dedication of our team. We have worked tirelessly to adhere to GMP principles, and this achievement validates our commitment to quality and excellence." - Naomi Allkins, Quality Assurance Manager.
This success is the culmination of years of hard work and dedication by the MET team in preparing for and adhering to Good Manufacturing Practice (GMP) principles. Our commitment to maintaining the highest standards of quality has been at the forefront of our operations, ensuring that every process and procedure meets stringent regulatory requirements.
In addition to our FDA success, MET also maintained its continuous accreditation with a successful UKAS audit in March. This audit confirmed that we have upheld our accreditation, reflecting our ongoing dedication to quality and excellence in every aspect of our work.
"We are immensely proud of our team's efforts and the recognition from both the FDA and UKAS. This milestone underscores our unwavering dedication to maintaining the highest standards in our testing services." - Angela Bell, General Manager of MET
The positive outcomes from both the FDA inspection and the UKAS audit underscore MET’s position as a trusted and reliable partner in the field of pharmaceutical and medical device testing. These achievements demonstrate our capability to meet and exceed regulatory standards, providing our clients with the confidence that their products are tested with the utmost precision and care.
"This significant achievement by MET highlights the strength and commitment of our entire organisation to quality and regulatory compliance. It reinforces our mission to improve patients’ lives by providing comprehensive testing services that enable our clients to launch and release their products safely and rapidly." - Mark Hammond, CEO of Cormica.
We are immensely proud of our team at MET for their hard work and perseverance. This milestone not only highlights our commitment to quality but also sets a solid foundation for future growth and success. As we continue to build on this achievement, Cormica remains dedicated to improving patient lives by providing comprehensive testing services that enable our clients to launch and release their products safely and rapidly across the world.
About Cormica
For more information about Cormica, Medical Engineering Technologies and our range of services, please visit our website www.cormica.com.