483
GA Analytical LLCGA Analytical LLC – FDA 483, Jan 16, 2013
Record Details
An FDA inspection of SA Analytical LLC's control laboratory in Mundelein, IL, revealed significant deficiencies in computer system controls and laboratory practices. The firm failed to ensure data integrity and proper user access for analytical software, and lacked adequate procedures for reviewing raw analytical data. Additionally, the inspection found issues with laboratory controls, including incomplete specifications for drug components and insufficient supplier qualification.
View Company Profile
ID · 9ba788cf-0f6d-4cd3-8394-364e92ecc7ea
Other documents for GA Analytical LLC
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.