FDA 483 - Pacific BioLabs - June 01, 2023

Pacific BioLabs, a control testing laboratory in Hercules, CA, was cited for significant deficiencies in its quality system and laboratory controls. The inspection revealed widespread failures to follow written procedures, inadequate investigation of deviations and out-of-specification results, and insufficient control over laboratory records and electronic data. These issues indicate a systemic breakdown in maintaining data integrity and ensuring the reliability of testing results.