FDA 483 - Spectrum Laboratory Products, Inc. - March 20, 2026

Spectrum Laboratory Products, Inc. in Gardena, CA, an API Repacker and Relabeler, was cited for significant deficiencies during an FDA inspection. The observations primarily concern failures in quality unit documentation, inadequate facility and equipment cleanliness, and a lack of proper validation and monitoring of cleaning procedures. These issues indicate a systemic breakdown in maintaining a state of control over critical quality operations.