Amgen’s Longmont, Colo., and Boulder, Colo., facilities received Form 483s for observations that range from inadequate investigations into quality failures to no validation of manufacturing processes.
Both facilities were inspected by the FDA in March. Investigators found at Longmont that Amgen personnel didn’t always follow up on certain quality issues. During the filling of a lot of epoetin drug substance, multiple post autoclaved and washed caps contained hair, silicone rubber and small steel particles.
While the affected caps were removed and not used in the process, investigators were concerned there was no “corrective and preventative action (CAPA) regarding the review of personnel gowning controls,” the FDA said.
In addition, no CAPA was taken for the silicone rubber gasket material used in the caps, and Amgen couldn’t find a root cause for the steel particles.
Amgen has responded to the agency and doesn’t “anticipate any disruption in manufacturing at either facility,” spokeswoman Kristen Davis said.