FAR Specialty Products, Inc. – FDA 483, Oct 3, 2022

An FDA inspection of Cyalume Specialty Products Inc., an API manufacturer in Bound Brook, NJ, revealed three significant observations. The firm lacked an effective quality agreement with its contract laboratory for microbial testing, failed to conduct temperature and humidity mapping for a warehouse storing temperature-sensitive materials, and did not have a written procedure for labeling reagents and standard solutions, leading to the use of expired reference standards.