Pace Life Sciences gets positive FDA review at San Germán plant
Pace Life Sciences LLC, a central laboratory and contract development and manufacturing organization, received an “overall positive review” from the Food & Drug Administration (FDA) after a comprehensive three-day inspection of its San Germán laboratory’s quality systems and data delivery processes.
“The success of this inspection is a positive reflection of our entire laboratory network, including the strength of our quality leadership, the team of highly experienced laboratory professionals, and our commitment to data integrity and compliance through robust quality systems,” said Lou Forcellini, head of Quality Assurance at Pace Life Sciences.
Forcellini added, “More than five years have passed since our previous U.S. FDA inspection in San Germán, and we have remained diligent. We host more than 60 client audits each year that challenge our system and ensure we are robust and up to date with current quality expectations.”
The Puerto Rico facility has a team of more than 60 bilingual chemists and microbiologists “who have decades of proven expertise and a strong track record supporting pharmaceutical and medical device clients from around the world,” the company stated.
In 2023, the 22,000-square-foot San Germán laboratory “achieved an average turnaround time of 10 working days for client projects, a remarkable industry benchmark,” Pace added.
Services provided at the laboratory include chemistry and microbiology testing, raw material clearance, in-process and final product testing, stability programs under International Conference on Harmonisation (ICH) guidelines, environmental monitoring, and studies on cleaning verification and disinfectant efficacy.
Pace is a portfolio company of Leonard Green & Partners and Los Angeles-based Aurora Capital Partners.
