FDA 483 - ALS Group USA, Corp - January 25, 2019

An FDA inspection of BioScreen Testing Services Inc in Torrance, CA, a control testing laboratory, revealed significant deficiencies in their quality system. Observations included a lack of software validation documentation, inadequate investigations into out-of-specification results and failures, incomplete laboratory records due to discarded original documentation, and failure to follow written production and process control procedures. These issues indicate a systemic breakdown in maintaining data integrity and ensuring product quality.