Catbird
Senior Moderator
Although the report (probably the FDA 483) of the inspection has been released to the media, it has not yet been posted on the FDA site.
FDA finds bugs, bird and contamination at Ameridose plant
"From a leaking ceiling in the so-called "clean room" and a bird flying through a room where sterile drugs are packed to basic problems with contamination and failures to investigate patient harm, the sister firm of the pharmacy at the heart of the deadly fungal meningitis outbreak had serious flaws in its drug-making process, federal officials said Monday.
Food and Drug Administration officials found conditions at Ameridose LLC of Westborough, Mass., so alarming during the month-long inspection between Oct. 10 and Nov. 9 that the agency urged the company to recall all of its products on Oct. 31 because there was no guarantee they were sterile.
...The new inspection included complaints of pregnant patients hemorrhaging after being given the labor-inducing drug oxytocin made by Ameridose, and reports of patients being over-sedated on the painkiller fentanyl -- or having no effect despite being given the maximum dose of a common children?s anesthesia drug, midazolam.
?Your firm?s Quality unit failed to appropriately classify ?patient response? complaints as adverse events,? the FDA inspectors wrote.
The report on Ameridose described cracked and peeling walls; gaps under the clean room doors; insects and ?at least one (1) bird? observed flying in the room where sterile drugs are packaged and stored. Similar inspections of NECC found filthy conditions in some rooms and both bacteria and fungus in packaged drug products made there.
...Those two were basic violations: failure to test finished drugs for sterility and for bacteria, as well as failure to confirm the potency of the final products.
Other problems included failure to investigate 53 instances of microbial contamination in sterile stock drugs used to make widely used injection drugs such as fentanyl and morphine, the new documents show.
In addition, firm officials also didn?t look into three instances this year when drugs failed sterility tests and they ignored 45 instances in which bacteria and mold were isolated from critical areas such as the fingers of workers preparing drugs inside sterile hoods.
Even when Ameridose officials did detect microbes, they failed to subculture them to find out precisely what they were, despite finding multiple contaminated units. Nor did they identify microbes found in the environment."
FDA finds bugs, bird and contamination at Ameridose plant
"From a leaking ceiling in the so-called "clean room" and a bird flying through a room where sterile drugs are packed to basic problems with contamination and failures to investigate patient harm, the sister firm of the pharmacy at the heart of the deadly fungal meningitis outbreak had serious flaws in its drug-making process, federal officials said Monday.
Food and Drug Administration officials found conditions at Ameridose LLC of Westborough, Mass., so alarming during the month-long inspection between Oct. 10 and Nov. 9 that the agency urged the company to recall all of its products on Oct. 31 because there was no guarantee they were sterile.
...The new inspection included complaints of pregnant patients hemorrhaging after being given the labor-inducing drug oxytocin made by Ameridose, and reports of patients being over-sedated on the painkiller fentanyl -- or having no effect despite being given the maximum dose of a common children?s anesthesia drug, midazolam.
?Your firm?s Quality unit failed to appropriately classify ?patient response? complaints as adverse events,? the FDA inspectors wrote.
The report on Ameridose described cracked and peeling walls; gaps under the clean room doors; insects and ?at least one (1) bird? observed flying in the room where sterile drugs are packaged and stored. Similar inspections of NECC found filthy conditions in some rooms and both bacteria and fungus in packaged drug products made there.
...Those two were basic violations: failure to test finished drugs for sterility and for bacteria, as well as failure to confirm the potency of the final products.
Other problems included failure to investigate 53 instances of microbial contamination in sterile stock drugs used to make widely used injection drugs such as fentanyl and morphine, the new documents show.
In addition, firm officials also didn?t look into three instances this year when drugs failed sterility tests and they ignored 45 instances in which bacteria and mold were isolated from critical areas such as the fingers of workers preparing drugs inside sterile hoods.
Even when Ameridose officials did detect microbes, they failed to subculture them to find out precisely what they were, despite finding multiple contaminated units. Nor did they identify microbes found in the environment."