483
GA Analytical LLCFDA 483 - GA Analytical LLC - January 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.
Open in Dashboard
ID · 9ba788cf-0f6d-4cd3-8394-364e92ecc7ea