Maker of eye drops linked to deadly outbreak flunks FDA inspection$1:
The facility, it seemed, was primed to produce contaminated products. FDA inspectors noted that Global Pharma didn't verify that components of the solutions, bought from suppliers, were sterile to begin with. And the areas of the facility where the solution was supposed to be made aseptically—contamination-free—weren't fit for producing sterile products. That is, the walls, ceilings, and floors were not smooth, hard surfaces that could be readily sterilized as they should be. Instead, there were cracks, protruding nails, and holes in the wall. But, even if the area was cleanable, the company's protocols for cleaning were also deficient, the report noted.
68 now sickened, 4 lose eyeballs in outbreak linked to eyedrops
FDA inspectors noted problems with cleaning and maintenance of machinery, which could have led to cross-contamination from other products manufactured in the facility. On the second inspection day, an inspector also noted a "black, brown colored greasy deposit" on parts of the filling machine, and the facility's equipment logbook noted that it hadn't been cleaned in nearly a month. A few days later, a manager told the inspector that there was "no procedure for cleaning" the filling machine.
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