Rentschler Biopharma, a German CDMO, was cited by the FDA with a Form 483 following an inspection that revealed nine observations focused on procedural gaps and records keeping.
FDA inspectors visited Rentschler’s drug substance facility in Laupheim, Germany, back in February. The privately held company has about 1,000 workers at its Laupheim headquarters and runs a manufacturing operation there.
Inspectors found the facility’s simulated fill process lacked a revolutions-per-minute specification for the pump and that there was no documentation for RPM settings during drug substance dispensing.
Additionally, two pieces of equipment had discolored rings below the top of the assembly, but no cause for the discoloration was indicated and no formal risk assessment or corrective action to address the discoloration had been taken, inspectors said.
The regulatory agency also cited the plant for not having lab procedures or testing to assure compliance with established specifications and standards available. Other equipment supporting manufacturing operations were not adequately validated, either, the FDA said.
Other observations included an inadequate system for monitoring environmental conditions of critical process equipment, facilities and equipment supporting the manufacturing process. Further, rejected materials weren’t always put under quarantine, the inspectors said.
Last August, Rentschler announced plans to expand its operations in the Boston area with a new facility that would increase production of complex molecules for clients in the U.S. When completed next year, the project will add 22,000 square feet of cleanroom space and will house four new 2,000-liter bioreactors.
Rentschler, like many CDMOs, has been spurred to expand its capabilities in cell and gene therapy manufacturing amid a boom in interest in the field. In addition, the company helped Pfizer and BioNTech produce their successful COVID-19 vaccines by handling downstream purification of manufactured mRNA.