Inconsistent reporting at a Pennsylvania site affected microbiological analyses of components and drug products that analytical testing service provider Eurofins ran for customers.
The FDA has hit Eurofins with a warning letter after the contract testing laboratory admitted “selectively recording test results.”
Eurofins performs microbiological analyses of components and drug products for customers. Across a business that serves multiple industries, Eurofins employs more than 65,000 people across more than 950 laboratories in 57 countries. The FDA observed compliance failings when it visited the company’s laboratory in Horsham, Pennsylvania, in June.
Inspectors found Eurofins failed to ensure that laboratory records included complete data from tests needed to ensure regulatory compliance. The concerns centered on pour plates for counting microorganisms.
Responding to the FDA, Eurofins said that analyst interviews and a retrospective review of laboratory data showed inconsistent reporting practices dating back to February 2025. The company acknowledged that some analysts were selectively recording test results, only documenting pour plate results in certain circumstances.
The FDA deemed Eurofins’ response inadequate for addressing the issues identified by agency inspectors. One inspector saw a Eurofins microbiologist fail to record results, according to the warning letter. The inspector also noted cracked and desiccated pour plate samples, which could no longer reliably support uniform microbial growth.
“A result recorded from a compromised plate, even one that falls within specification, cannot be considered valid, as the physical condition of the media may have suppressed or obscured actual microbial recovery,” the agency said.
The FDA also found fault with Eurofins’ data review procedure. One failing illustrated “the unreliability of your data, and further demonstrates that lack of secondary verification is unacceptable,” the FDA said.
Another section of the warning letter focused on Eurofins’ failure to thoroughly investigate the cracked or desiccated plates used for testing raw material and drug product samples. The company told the FDA that it investigated the scope of affected samples and the adequacy of results. Based on analyst interviews and a limited records review, Eurofins concluded the results were valid, according to the letter.
The FDA again found Eurofins’ response inadequate. Lacking photographic evidence of plate conditions, the agency saw no basis to retroactively confirm any results. Eurofins’ conclusions relied solely on analyst interviews and data records that the company acknowledged are unreliable, the FDA said.
“Data integrity depends on complete and accurate documentation of test results and conditions. Failure to maintain such records undermines the reliability of your data,” the agency wrote to Eurofins. “The use of deficient media similarly compromises the validity of microbiological test results and raises questions about the suitability and robustness of your methods.”
Eurofins was one of several companies to receive a manufacturing-related warning letter in the FDA’s latest batch of compliance notices. The FDA also issued warning letters to Korea’s Hanlim Pharm and the U.S. 503B outsourcing facility SCA Pharmaceuticals. FDA inspectors found poor aseptic practices and inadequate cleaning at Hanlim’s plant. SCA received its warning letter for drug compounding failures.
