FDA 483 - Spectrum Laboratory Products, Inc. - November 13, 2018

Spectrum Laboratory Products Inc. in Gardena, CA, a repacker/relabeler, was cited with three observations during an FDA inspection. The firm failed to ensure Certificates of Analysis for repackaged APIs included original manufacturer details and lacked traceability in relabeling operations. Additionally, the quality management system was found inadequate, with failures in conducting investigations for product issues and determining root causes for complaints.