FDA warning letter to Eurofins contract micro lab cites missing TNTC results and counts from damaged plates

On October 13, 2026, FDA posted an October 6, 2026 warning letter to Eurofins SF Analytical Laboratories, Inc., a contract testing laboratory that performs microbiological analyses of drug components and drug products for its customers. FDA inspected the lab at 215 Witmer Road, Horsham, Pennsylvania, from June 1 to 3, 2026, and cited violations of the drug CGMP regulations in 21 CFR parts 210 and 211. According to the letter, a microbiologist recorded only pour plate counts and left out the results of a second plating method when those plates were too numerous to count (TNTC). Counts were also recorded as within limits from plates whose media was cracked and desiccated, and the investigator found a colony on a plate that an analyst had recorded as 0 CFU.

FDA notes that the lab's data review procedure did not require secondary verification of plates read as 0 CFU, and that several cracked or dried plates recorded as 0 CFU were discarded without a second analyst's review. In its response, the lab acknowledged inconsistent reporting practices dating back to February 2025. FDA called the response inadequate because it did not address whether certificates of analysis issued to customers were affected. The letter asks for an independent assessment of the laboratory, a CAPA plan for microbiological media overseen by a qualified consultant, full sample custody and reconciliation records, and digital time-stamped photos of all plates at the time of reading. FDA also recommended that the firm engage a qualified CGMP consultant.