According to press reports of a recent FDA inspection, Global Pharma, the maker of eye drops linked to a deadly outbreak of drug-resistant infections in the US had a slew of manufacturing violations—from brown slime on filling equipment to a lack of basic measures and systems to ensure sterility—according to an inspection report released by the Food and Drug Administration – PDF.
As of March 14, 68 people in 16 states have been infected with the strain, the Centers for Disease Control and Prevention reports. Three people have died from the infection, eight have lost vision, and four have had their eyeballs surgically removed.
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.
The FDA found that the walls, ceilings, and floors were not smooth, hard surfaces that could be readily sterilized. 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.
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 “black, brown colored greasy deposit” on parts of the filling machine, and the facilities 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.
Environmental monitoring for contamination in the facility was also lacking, the report found. And the sterility of primary packaging—including bottle caps—were not verified before they were used. Once the eye drops were bottled, the formula did not contain a preservative to prevent microbial contamination, and batches were released to the US without going through the quality control unit.