Roche subsidiary Genentech received a Form 483 from the FDA after an inspection found parts of the processing area for making active pharmaceutical ingredients (APIs) was covered with what resembled rust.
During an August to September inspection of the drugmaker’s Vacaville, Calif., facility, investigators concluded that the weighing and dispensing booths for processing APIs are not in a sanitary condition and in disrepair.
Findings include a substance that resembled rusting metal on numerous bolt heads, flaking paint around the bottom perimeter of the vertical walls and stainless steel wall panel joints that were worn off.
Investigators also discovered a stainless steel cover plate on the back wall that was missing one of two screws and the cover plate was partially swung out of place.
Additionally, the water system the facility uses to make APIs had leaks, reads the four-observation form.
Investigators also chided Genentech for an inadequate investigation into why numerous cell banks thawed out. Genentech attributed the thawing to multiple relocations of the cell banks. The drugmaker did not investigate whether potential thawing happened to other cell banks, the form reads.
Genentech is in the process of addressing all of the observations noted in the form, and that effort is not expected to disrupt drug substance manufacturing operations at the Vacaville facility, spokeswoman Nadine Pinell said.
Sometimes there are problems that you can control. Global Compliance Investigative Services will show you how to control what you can, as best you can, so that those FDA warnings never come to you. Order yours now.