Rechon Life Sciences, a Sweden-based pharma contract manufacturer, was hit with a warning letter from the FDA following an inspection that uncovered unsanitary conditions at its production plant.
The U.S. regulatory agency outlined four observations recorded during its inspection of the facility in Malmö, Sweden, between August 26 and September 6, 2024.
The warning letter was issued on April 30, 2025, and published to the agency's website earlier this month.
During the visit, FDA inspectors found that the company didn’t follow guidelines aimed at preventing microbiological contamination of sterile drug products, and that it didn't investigate unexplained discrepancies or batch failures, according to the warning letter.
Additionally, the FDA wrote up Rechon for not using adequate procedures to prevent the growth of certain bacteria species in aseptic filling lines.
Rechon was also reprimanded for not properly maintaining classified areas and cleanrooms used in the manufacture of drug products. During the inspection, FDA inspectors found peeling paint on the ceiling as well as bubbled paint and rust at the bottom of the door in a room leading to an aseptic filling line.
Failing to address the issues uncovered by the inspection could result in the agency refusing to allow drugs produced by Rechon at the facility to be allowed into the U.S., according to the letter.