Simtra Biopharma Solutions recieved a warning letter from the FDA after an inspection uncovered several issues at the CDMO’s production plant in Halle, Germany.
The rebuke from the U.S. regulatory agency comes in the wake of an inspection of the facility conducted between September 18-26 last year, which resulted in two violations concerning contamination.
The agency chided Simtra—which rebranded from Baxter BioPharma Solutions in 2023—for failing to conduct operations in a manner that prevents contamination or mix-ups in its aseptic processing areas.
Among the issues inspectors found was the “extensive” use of an unnamed liquid to rinse surfaces of aseptic processing “through excessively long” deadlegs, which are stagnant, low-flow, or non-circulating sections of piping that can present significant contamination risks because they're tough to clean.
Additionally, the FDA cited testing between June 2023 and September 2025 that resulted in at least 47 microbial recoveries at the Simtra site, including 14 that exceeded acceptable limits.
“Furthermore, post-production environmental monitoring samples taken within your ISO 5 and RABS [Restricted Access Barrier Systems] between June 2023 and September 2025 have resulted in repeated recoveries of gram-negative organisms including Sphingomonas, Methylobacterium, and Cupriavidus species,” the agency said in its letter.
Simtra was also cited for failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of sterile drug products.
Elsewhere, Simtra recently expanded its manufacturing footprint at its fill-finish facility in Bloomington, Indiana, acquiring a 65-acre property last July that provides 300,000-square-feet of usable space. That land deal was separate from a $250 million expansion at the site announced in February 2025.