San German, PR, September 6, 2011 – Pace Analytical Life Sciences (PLS) announces a successful and favorable outcome following completion of a three-day site audit from a Food & Drug Administration (FDA) Consumer Safety Officer in the Puerto Rico District Office. The audit by FDA resulted in no FDA-483 observations. Once available from the FDA, copies of the Establishment Inspection Report (EIR) will be available to PLS’ clients upon request. The audit by FDA was initiated as a Routine Inspection audit and was hosted in the San German laboratory during the first week of September 2011.
This audit was the second FDA inspection of the Pace Analytical Life Sciences’ Quality System in 2011. During the first week in February, the Pace Analytical Life Sciences Oakdale (Minnesota) Laboratory hosted a four-day audit from a Food & Drug Administration (FDA) Consumer Safety Officer in the Minneapolis District Office. The Oakdale audit by the FDA was initiated as a Routine Inspection audit and transitioned to a Pre-Approval Inspection (PAI). This audit also resulted in no FDA-483 observations.
In total, the Pace Analytical Life Sciences’ Quality System was inspected by two different inspectors, originating from two different districts for a total of 7 days in 2011. A wide range of data including–but not limited to– extractable/leachable data, method validation, stability testing and storage, microbiology, raw material testing, medical device testing, equipment qualification/calibration/maintenance, software validation and investigation records were reviewed during these audits without a single FDA-483 being issued to either site. Steve Vanderboom, CEO of Pace Analytical Life Sciences, commented, “The result of the San German audit, combined with the successful audit in Oakdale, is a strong statement to our clients regarding our commitment to quality. It should provide our customers with confidence when selecting Pace as a GMP laboratory outsourcing partner.”
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. Pace Analytical Life Sciences operates two laboratories, one located in Oakdale, Minnesota, and the other in San German, Puerto Rico. We are FDA registered, DEA licensed and ISO/IES 17025 accredited.
Contact:
Jim Wheeler
Pace Analytical Life Sciences, LLC
Director, Business Development
1311 Helmo Avenue N.
Oakdale, MN 55128
(651) 294-0807 office
james.wheeler@pacelabs.com