German manufacturer hit with Form 483 for multiple production issues
After an inspection in February, the FDA has revealed concerning observations at a manufacturing facility belonging to Rentschler Biopharma in Germany.
The facility, a drug substance manufacturing site in the small southern German city of Laupheim, had nine observations noted by FDA inspectors.
The first observation noted that the simulated fill process had no RPM specification for the pump and no documentation for RPM settings during drug substance dispensing to be avoided. The process is also not controlled to an established specification.
The inspection also found two redacted pieces of equipment having rings of discoloration below the top of the assembly, with no root cause indicated and no formal risk assessment or corrective action to address the discoloration.
Laboratory procedures or testing to assure compliance with established specifications and standards are not available, FDA said. Equipment and facility systems in support of manufacturing were also not adequately validated.
The FDA found that rejected materials are not always controlled to prevent their unauthorized use and rejected materials were not always controlled under quarantine.
The company also failed to establish an adequate system for monitoring environmental conditions of critical process equipment, facilities and equipment in support of manufacture.
This comes at a time when Rentschler is making several moves. The company expanded its site in Massachusetts last year, and has been looking to bump up its investment in cell and gene therapies over the next five years. The German CDMO opened a new site at the Cell and Gene Therapy Catapult in the UK, allowing Rentschler to establish the manufacturing of viral vectors for clinical supply.