FDA 483 - Spectrum Laboratory Products, Inc. - March 15, 2023

The FDA inspection of Spectrum Laboratory Products, Inc. in New Brunswick, NJ, revealed widespread deficiencies across its repackaging, quality control, and quality management systems. Significant issues include inadequate environmental controls, unvalidated cleaning procedures, poor material traceability, and insufficient investigations into out-of-specification results and deviations. These findings indicate a serious lack of control over critical processes, posing a risk to product quality and integrity.