Company commitment to quality excellence confirmed during FDA Inspection
SAN GERMÁN, PR / ACCESS Newswire / August 21, 2025 / Pace® Life Sciences, a U.S.-based contract, research, development and manufacturing organization (CRDMO) and full-service FDA-registered GMP Analytical Testing laboratory announced today that its San Germán, Puerto Rico site has received a positive FDA Inspection of its quality systems and client data delivery processes. This marks the second positive inspection outcome for this facility since March 2024.
"As we continue to support our clients bringing drugs to market, we recognize the critical importance of strong quality systems and reliable data," stated Lou Forcellini, Head of Quality Assurance at Pace® Life Sciences. "Our confirmed commitment to data integrity and compliance provides added assurance that Pace® is a trusted partner throughout the entire drug development and manufacturing process."
The San Germán location boasts over 22,000 square feet of chemistry and microbiology laboratory space and holds US FDA and the US Drug Enforcement Agency (DEA) registrations. Primary services offered at this site include chemistry and microbiology laboratory testing, raw material clearance programs, in-process and finished product testing, ICH stability programs, facility environmental monitoring programs, and cleaning verification/disinfectant efficacy studies.
Pace® is a portfolio company of Leonard Green & Partners and Los Angeles-based Aurora Capital Partners.
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ABOUT PACE® LIFE SCIENCES
Pace® Life Sciences provides a full suite of contract CMC development, clinical trials materials manufacturing, regulatory compliance, consulting, and facility support services to the pharmaceutical, biopharmaceutical, and gene therapy industries. Our network of CDMO sites consists of GMP analytical testing laboratories and manufacturing support service centers. Our experienced, highly trained industry experts and our investment in state-of-the-art development and manufacturing facilities emphasize our commitment to efficiently advancing client programs through the clinic to commercialization. We are dedicated to delivering the best and most reliable services with positive customer experiences across all channels of our business. More at PACELIFESCIENCES.com.
Contact Information
Pam Bednar
Marketing Director
pam.bednar@pacelabs.com
612-297-0651
Brooke Schwartzel
Brand & Communications Manager
brooke.schwartzel@pacelabs.com
612-656-2241
SOURCE: Pace® Analytical
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/business-and-professional-services/pace-life-sciences-san-germ%c3%a1n-site-receives-positive-inspection-1062805
