FDA 483 - Pace Analytical Inc. - August 07, 2025

Pace Analytical Inc., a contract testing laboratory in San German, PR, was cited for significant deficiencies in its laboratory control mechanisms and documentation practices. The inspection revealed failures in documenting reference standards, managing expired media, and maintaining microbial control standards, indicating a lack of adherence to established procedures. Additionally, the firm failed to invalidate and properly document the handling of out-of-specification results for compressed air monitoring, raising concerns about data integrity and product quality assurance.