FDA 483 - GA Analytical LLC - March 28, 2014

An FDA inspection of SA Analytical LLC, a prescription drug contract laboratory in Mundelein, IL, revealed a significant deficiency in the firm's quality control systems. The primary concern was the inadequate routine calibration, inspection, and checking of electronic equipment, specifically the stability chamber environmental monitoring and recording system. This issue led to failures in identifying, recording, and investigating out-of-tolerance temperature and relative humidity excursions, indicating a lack of control over critical environmental data.