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483
•Creative Testing Solutions•August 29, 2025

FDA 483 - Creative Testing Solutions - August 29, 2025

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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.

Company
Creative Testing Solutions
Inspection Date
August 29, 2025
Product Type
Biologics
Office
Denver District Office
People
  • Emily S. McGann
  • William F. Lagud
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ID · 1b946a26-ef8e-41e5-9ed9-e2896aaf8644

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