Particle Technology Labs takes great pride in the successful completion of our 2024 Food and Drug Administration (FDA) general compliance inspection. This marks our 30-year run with an FDA observation-free record.
“We are excited to, once again, complete a successful FDA inspection, validating our daily commitment to quality and continuous improvement. We are thankful for the efforts of our staff members who keep quality paramount in each analysis and each interaction with clients,” remarks Amy Ganden, PTL’s Quality Assurance and Methods Compliance Manager.
This FDA inspection resulted in no observations and is classified as NAI (no action indicated). Over three days in October, the FDA inspection team assessed our:
• Facility
• Analytical instruments
• Quality management
• Implementation of the requirements
These critical areas were found to conform to the US FDA cGMP’s stringent requirements. The FDA objectively reviewed the evidence of PTL’s quality management system procedures. For example, FDA inspectors analyzed completed investigations, nonconformances, and CAPAs to see that they were executed correctly.
We are very grateful to our skilled team, whose expertise and knowledge made this a smooth and collaborative process.
Why is this important to our pharmaceutical customers and their consumers? To many, “FDA cGMP” may seem like a jumble of letters. However, passing such inspections—with flying colors–validates PTL’s commitment to quality and expert analysis. PTL customers can be confident in our services and data to the pharmaceutical industry. Our particle characterization lab plays an important role in helping ensure the quality and safety of products delivered to end users. In fact, PTL hosts over 30 audits per year from the world’s leading pharmaceutical companies.
Particle Technology Labs is a trusted advisor to the world’s leading pharmaceutical, industrial, public sector, and scientific organizations. Our scope and expansive knowledge of particle technology allow us to provide the insights you need to make the right decisions for your organization.
