FDA 483 - Eurofins Food Chemistry Testing Madison, Inc.

Eurofins Food Chemistry Testing Madison, Inc. in Madison, WI, was inspected from September 15-17, 2025, and received a Form 483 for deficiencies in its laboratory controls. The inspection revealed that the firm's stability testing program lacked scientifically sound specifications for sampling plans, impacting the assurance of drug product quality. Specific issues included improperly controlled stability chambers, discrepancies in sample inventory and identification, and inadequate procedures for temperature excursions.