Particle Technology Labs (PTL) announces the successful completion of its most recent U.S. Food and Drug Administration (FDA) general compliance inspection, continuing the laboratory’s long-standing record of regulatory excellence.
The multi-day inspection included a comprehensive review of PTL’s quality systems, laboratory operations, and analytical practices. The inspection concluded with no observations, meaning no Form 483 was issued.
This result extends a remarkable record for Particle Technology Labs.
For three decades, PTL has maintained an observation-free FDA inspection history, reflecting the laboratory’s consistent commitment to quality systems, regulatory compliance, and methodological excellence.
The FDA investigator conducted a thorough review of PTL’s operations during the visit. As is typical for this type of inspection, significant attention was placed on examining the handling of quality events, such as complaints, nonconformances, deviations and investigations.
During the inspection, the investigator also:
- Observed real-time analytical testing in the laboratory
- Reviewed personnel training records to confirm staff qualifications
- Examined the recent analytical instrument qualification of PTL’s Malvern Panalytical Zetasizer Advance Pro Blue
- Evaluated method validations and method transfers
- Reviewed documentation supporting PTL’s quality system and data integrity practices
The successful inspection reinforces the strength of PTL’s systems, the expertise of staff, and the culture of quality embedded throughout the organization.
Amy Ganden, PTL’s Quality Assurance and Methods Compliance Manager, said, “I am proud that PTL once again had a successful, observation-free FDA inspection. Every day, we work to build a quality-focused environment so that our clients can trust the data we provide and have confidence PTL is operating in compliance with CGMP regulations. This inspection confirmed this commitment to quality and continuous improvement.”
Kelli Hubert, PTL’s Internal Operations Manager, recognizes the importance of Amy’s guidance and the team’s commitment to maintaining PTL’s strong regulatory track record.
“Once again, Amy Ganden has led PTL through a rigorous FDA inspection with the excellence and composure she brings to every challenge,” noted Kelli. “Her deep knowledge, meticulous standards, and dedication to our quality system shine through in our continued streak of inspections without a 483. This success also reflects the commitment of every PTL staff member, whose consistent adherence to our quality standards makes achievements like this possible. We are grateful for Amy’s leadership and for the collective effort that upholds the quality culture she champions,” said Kelli.
For PTL’s pharmaceutical and regulated industry clients, successful FDA inspections provide an important level of assurance. Compliance with current Good Manufacturing Practices (cGMP) demonstrates that PTL’s laboratory processes consistently meet rigorous expectations for quality, documentation, and data reliability.
Through its expertise in particle characterization and its commitment to strong quality systems, Particle Technology Labs continues to support pharmaceutical, medical device, biotechnology, and materials science organizations around the world with trusted analytical insight.
For more about Particle Technology Lab’s quality management system, visit: https://particletechlabs.com/quality-systems/
