483
Creative Testing SolutionsFDA 483 - Creative Testing Solutions - August 29, 2025
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
Creative Testing Solutions in Tempe, AZ, a testing laboratory, received a Form 483 with two observations. The inspection revealed failures to follow manufacturer's instructions for communicable disease agent testing, specifically concerning reagent reservoir use and cleaning. Additionally, the firm failed to thoroughly investigate and document unexplained discrepancies, including issues with quality control lot numbers and reference ranges.
Open in Dashboard
ID · 1b946a26-ef8e-41e5-9ed9-e2896aaf8644