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.
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