Pace Analytical Inc. – FDA 483, Aug 7, 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.
ID · d8d219fc-9ada-4967-b528-1406871c23f2
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.