483
Pacific Science LLCPacific Science LLC – FDA 483, May 28, 2026
Record Details
Pacific Science LLC, a biorepository stability storage facility in El Segundo, CA, was cited for significant deficiencies related to its quality control unit. The inspection revealed a lack of a written quality agreement with a sponsor for a combination drug/device product, leading to ambiguity in responsibilities for stability sample storage and equipment maintenance. Additionally, the firm could not provide a sponsor-approved stability protocol.
View Company Profile
ID · 87f8fd17-bab6-46d8-9777-c36f698eb6c8
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.