Pace Life Sciences Earns Positive US FDA Inspection Review In Puerto Rico

Pace® Life Sciences, LLC, a leading full-service FDA-registered central laboratory and contract development and manufacturing organization (CDMO), recently announced a significant achievement following a comprehensive three-day inspection by The Food & Drug Administration (FDA). The inspection, which focused on the company's quality systems and client data delivery processes at its San German, Puerto Rico laboratory, concluded with an overall positive review. This marks a notable milestone for the organization, reflecting its commitment to maintaining high standards in quality and compliance.

Lou Forcellini, the Head of Quality Assurance at Pace® Life Sciences, expressed his satisfaction with the inspection results. He highlighted the collective effort of the laboratory network, emphasizing the role of quality leadership, the expertise of laboratory professionals, and the adherence to robust quality systems in achieving this success. Forcellini also noted that it had been over five years since the last US FDA inspection at the San German site. Despite this interval, the company has consistently demonstrated its dedication to quality through more than 60 client audits annually.

The San German operation boasts a team of over 60 fully bilingual chemists and microbiologists. These professionals bring decades of experience and a strong track record in supporting pharmaceutical and medical device clients globally. In 2023, this laboratory set an industry benchmark by achieving an average turnaround time of 10 working days for client projects. The facility spans over 22,000 square feet, offering extensive chemistry and microbiology laboratory space. It is registered with both the US FDA and the US Drug Enforcement Agency (DEA), providing a range of services including Chemistry & Microbiology Laboratory Testing, Raw Material Clearance Programs, In-Process & Finished Product Testing, ICH Stability Programs, Facility Environmental Monitoring Programs, and Cleaning Verification/Disinfectant Efficacy Studies.

Pace® Life Sciences is part of a portfolio managed by Leonard Green & Partners and Los Angeles-based Aurora Capital Partners. The company offers comprehensive contract CMC development, clinical trials materials manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Its network includes GMP analytical testing laboratories and manufacturing support service centers staffed by experienced industry experts. This infrastructure underscores Pace®'s commitment to advancing client programs efficiently from clinical stages to commercialization.

At its core, Pace® aims to make the world a safer and healthier place through its contributions to the pharmaceutical and biotechnology industries. Its laboratories and supporting businesses play a crucial role in advancing science while offering local-level service backed by a national laboratory network. For customers with in-house labs, Pace® also provides a range of professional services to enhance operational efficiency. The company's dedication to delivering reliable services and fostering positive customer experiences across all business channels remains unwavering.

For more information about Pace® Life Sciences and its services, visit pacelifesciences.com.