FDA 483 - Spectrum Laboratory Products, Inc. - February 19, 2025

An FDA inspection of Spectrum Laboratory Products, Inc. in New Brunswick, NJ, identified multiple deficiencies in their repackaging and quality control operations for active pharmaceutical ingredients (APIs). Key issues included inadequate testing procedures for repackaged APIs, unverified test methods, and the absence of a stability testing program. Additionally, the firm failed to maintain suitable storage conditions, perform routine balance calibration according to procedures, and validate computer software for analytical equipment.