FDA 483 - Spectrum Laboratory Products, Inc. - July 14, 2021

Spectrum Laboratories Inc, a chemical manufacturing corporation in New Brunswick, NJ, was cited with six observations during an FDA inspection. The observations primarily concern significant deficiencies in laboratory controls, data integrity, and quality assurance practices related to the testing, repackaging, and release of Active Pharmaceutical Ingredients (APIs). These issues indicate a lack of robust systems to ensure the quality, purity, and strength of distributed drug products.