FDA 483 - Chromak Research Inc - July 11, 2024

Chromak Research Inc., a control testing laboratory in Metuchen, NJ, was cited for significant deficiencies across its quality system, personnel training, facility and equipment maintenance, and data integrity. Observations included a lack of written procedures for quality control, inadequate training records for the lab director, unsanitary conditions in testing areas and equipment, and insufficient data backup and validation practices. These issues indicate a systemic failure to ensure the quality and purity of drug products tested.