Roche unit Genentech has been called on manufacturing anomalies following an inspection of the California plant where it makes Avastin. Particle contamination and disintegrating gaskets were part of the trouble. But incomplete investigation reports and the FDA's pointing out the report shortcomings a few months earlier may prove bigger concerns.
"Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not include the conclusions and follow-up," inspectors write in the first observation. "THIS IS A REPEAT OBSERVATION FROM 06/2011" [caps are FDA's].
The FDA inspection report was released in late September, reports Dow Jones. Genentech workers found particle contamination in some vials of the cancer drug. And they found disintegrating gaskets in a vial washer. They sent the particle-contaminated vials for analysis but neglected to look for a match between the particles and the gaskets, according to Dow Jones.
In addition, capper problems during the fill operation of an Avastin lot prompted another company investigation. But this investigation report neglected to detail the actions workers took to address a capper oil leak the investigation uncovered. Nor did the report include the disposition of the in-process vials during a multiple-hour shutdown for repairs.
"There is no documentation to provide assurance that the capper oil leak was addressed/repaired prior to the resumption of manufacturing," inspectors state on the Form 483. "Additionally, there is no documentation to provide assurance that the in-process filled/stoppered vials were handled according to company procedures."
- here's the article
- see the Form 483 inspection report (.pdf)