FDA Warning Letter to Eurofins Flags Microbial Analytical Practices

USFDA has issued a Warning Letter to Eurofins SF Analytical Laboratories, Inc, Contract Testing Laboratory at Horsham, Pennsylvania in US (FEI 3014704316) citing lapses in Microbial Analysis practices and lack of Quality oversight. The laboratory was inspected by FDA inspector Pushpa Suresh Jayasekara from 1 to 3rd June, 2026.

Key microbiological testing deficiencies cited by FDA

• Failure to record TNTC results: The microbiologist failed to record results assessed as too numerous to count (TNTC), recording only the pour plate counts.
• Incorrect recording of zero counts: The FDA investigator identified a colony on a plate recorded as 0 CFU by the analyst.
• Selective reporting of results: Analysts selectively recorded results, omitting TNTC findings from the complete test record.
• Acceptance of compromised plates: Pour plate counts were recorded as within acceptable limits despite the plates being cracked and desiccated which could compromise microbial results.
• Absence of secondary verification: There was no secondary verification when an initial plate count was recorded as 0 CFU. Several samples with desiccated and cracked plates were recorded as zero counts and discarded without secondary analyst review.
• Inadequate investigation and Quality Unit oversight: The laboratory failed to adequately investigate aberrant media conditions and demonstrate the reliability and completeness of historical test results.

GMP implications, Corrective Actions Required

These findings point to deficiencies in microbiological testing practices, laboratory documentation, data review, deviation investigation and Quality Unit oversight. This compromise the reliability of microbiological results; ability to demonstrate that tested materials and products comply with established specifications.

For robust microbiological analytical controls and practices, Laboratories must ensure

• Procedures define criteria for acceptable plate microbiological plate condition, document observation of cracked, desiccated or otherwise compromised plates
• Recording of all test observations – TNTC, 0 (Zero) CFU counts and other atypical results
• Secondary verification of zero-count results
• Investigation, documentation and scientifically justified disposition of invalid or compromised results. Investigations should also perform impact assessment of potentially affected historical results
• Adequate Quality Unit (QA/ QC) oversight, analyst training and competency to ensure compliance and data integrity

The FDA Warning letter to Eurofins also recommended digital time-stamped photos of all microbiological plates at the time of reading to ensure photographic evidence to support all results

Warning Letter: Eurofins SF Analytical Laboratories, Inc. – 10/06/2026 | FDA