483
Spectrum Laboratory Products, Inc.FDA 483 - Spectrum Laboratory Products, Inc. - November 13, 2018
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · 5e785bcb-b554-48aa-9e7d-1cdecc704e6a