Nov. 12, 2012 at 5:34 PM ET
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.
Ameridose is co-owned by Barry Cadden, the owner of the New England Compounding Center, the pharmacy blamed for fungal meningitis infections that have sickened 438 people in 19 states and caused 32 deaths. Cadden and his brother-in-law, Gregory Conigliaro, started both firms.
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.
No infections have been linked to Ameridose products, FDA officials said. But the possibility of serious harm is evident in the report that details 15 observations, including two that were first documented in 2008.
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.
“Without knowledge of identity of microbes found during environmental monitoring, your firm lacked critical information to investigate possible root causes of sterility problems,” FDA inspectors wrote.
Ameridose officials defended the company's practices in a statement:
"While Ameridose’s history shows clearly that we have not had any instance of contaminated products over the course of the past six years, which covers the manufacture and shipment of 70 million units of product, and have always been guided by Good Manufacturing Practices (GMP) referenced in federal regulations, Ameridose is committed to addressing all observations in order to enhance our existing systems. We are in the process of preparing a full response for presentation to the FDA.”