FDA issues warning to Eurofins over selective microbiology data recording at Pennsylvania lab
FDA sent a warning letter to Eurofins after inspectors found issues at its Horsham, Pennsylvania laboratory.
The inspection revealed that analysts had been selectively recording results of pour-plate microbiological tests, omitting data in certain cases, which compromised the completeness of records required for regulatory compliance.
Eurofins said a review traced the practice back to February 2025, but the agency judged the company's response insufficient and highlighted the risk to product quality assurance.
The company, which operates over 950 labs worldwide, now faces heightened scrutiny and must take corrective actions to restore confidence in its testing services.
This writeup was produced by pharmadog from original reporting by BioSpace.
Original headline: “FDA issues warning over Eurofins’ selective recording that "compromises" data”
read at BioSpace ↗
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