FDA 483 - Pace Analytical Life Sciences, LLC - May 29, 2026
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Pace Analytical Life Sciences, LLC, a contract testing laboratory in Oakdale, MN, was cited for significant deficiencies in its quality control systems. The inspection revealed inadequate controls for stability chambers, leading to multiple freezer excursions and a lack of formal backup procedures and verified training. Additionally, the firm had widespread issues with laboratory records, including incomplete data, unattributable entries, and repeated breaches of client data confidentiality, indicating a systemic failure in data integrity and record management.
ID · 7b76ce4d-eb11-4ba7-9e13-48dad3e6b8bf