Oakdale MN, March 25, 2011 – Pace Analytical Life Sciences (PLS) announces successful and favorable outcomes following completion of a four-day site audit from a Food & Drug Administration (FDA) Consumer Safety Officer, Minneapolis District Office, and an ISO surveillance audit.
The audit by FDA resulted in no FDA-483 observations. Once available from FDA, copies of the Establishment Inspection Report (EIR) will be available to PLS clients upon request.
The audit by FDA initiated as a Routine Inspection audit and transitioned to a Pre-Approval Inspection (PAI). The audit was hosted in the Oakdale, MN, laboratory during the first week of February, 2011.
Also during the first week of February, Pace Analytical Life Sciences hosted its annual ISO surveillance audit. The 1-day audit outcome was successful and PLS maintains ISO 17025 accreditation.
Gregory Kupp, VP/COO of Pace Analytical Life Sciences, commented, “We were extremely pleased with the success of our recent regulatory audits. The outcomes affirm our commitment to delivering quality data to support our clients in the pharmaceutical and medical device industries. Our business has enjoyed robust growth during the past 3 years since our last FDA audit, and we have remained focused on our Quality Management System.”
Pace Analytical Life Sciences is a full-service contract analytical testing laboratory providing chemistry and microbiology testing services to the pharmaceutical and medical device industries. Services include methods development/validation, raw material testing, stability testing and storage, product release testing, chemical characterization, and residual chemical analysis.
Contact:
Jim Wheeler
Director, Business Development
Jim.wheeler@pacelabs.com
Jim Wheeler at (651) 294-0807