What happened
FDA states that its June 1–3, 2026 inspection of Eurofins SF Analytical Laboratories’ contract testing facility identified significant finished-drug CGMP violations in microbiological testing and quality oversight. Analysts did not record certain results assessed as too numerous to count and selectively documented results, while cracked and desiccated plates were reported as within limits or as 0 CFU. FDA also observed a colony on a plate recorded as 0 CFU. The procedure did not require secondary verification of initial zero counts, and compromised plates were discarded without secondary review. FDA found that aberrant media conditions were not thoroughly investigated; the firm’s retrospective conclusions relied on interviews and records it acknowledged were unreliable, without photographic evidence of plate conditions. FDA considered the response inadequate because it did not assess effects on certificates of analysis or customers, verify historical data completeness, or commit to discontinuing damaged plates. FDA further stated that the quality unit lacked adequate authority, oversight, and control over laboratory operations and requested independent assessments, CAPA, stronger investigation systems, sample custody controls, photographic documentation, and quality-unit remediation.
Why it matters
From a GMP and pharmaceutical manufacturing perspective, omitted results, inaccurate zero counts, and testing with damaged media may conceal microbial growth or suppress microbial recovery, undermining the validity of test results. Incomplete records can also impair review of historical data, certificates of analysis, investigations, and quality-unit disposition decisions. FDA’s observations indicate broader concerns about laboratory controls, documentation reliability, investigation effectiveness, CAPA, and whether the quality unit can maintain adequate oversight and a continuing state of control.
Key topics: Selective omission of TNTC microbiological results, Use of cracked and desiccated microbial plates, Inadequate quality unit oversight of laboratory operations