FDA 483 - ALS Group USA, Corp - June 05, 2023

An FDA inspection of ALS Group USA, Corp in Torrance, CA, a contract testing laboratory, from May 31 to June 5, 2023, identified one significant observation. The firm was cited for using equipment for preparing and sterilizing microbiological media for drug product testing beyond its scheduled requalification date. This indicates a failure to maintain equipment in a qualified state for its intended use.