Federal inspectors found crawling insects, corroding walls and concerns about safety and quality safeguards at a drug-making facility run by the company tied to a deadly meningitis outbreak, according to a report released today.
The U.S. Food and Drug Administration issued its report after a nearly month-long investigation of a Massachusetts plant run by Ameridose. Tainted injectable steroids from the now-closed New England Compounding Center, a compounding pharmacy that is a sister company of Ameridose and is run by the same management, are blame for 32 deaths out of 428 cases of presumed fungal meningitis and 10 peripheral joint infections in 19 states, the U.S. Centers for Disease Control and Prevention said.
Ameridose issued a statement later Monday playing up its record and saying it is "in the process of preparing a full response for presentation to the FDA."
"While (our) history shows clearly that we have not had any instance of contaminated products over the course of the past six years, ... Ameridose is committed to addressing all observations in order to enhance our existing systems," the company said.
Ameridose's drug-manufacturing facility is licensed and regulated by the FDA.
Since 2007, the company has received more than $800,000 in drug orders from federal agencies, including the Department of Defense and Department of Veteran Affairs, according to federal records. That number was confirmed by the company and by the FDA.
According to Monday's FDA report, Ameridose got about 33 complaints its products were ineffective or caused "patient response events" different than they should have. These included drugs such as Oxycontin, Ephedrine and Fentanyl that "were not tested for potency" before being distributed, the FDA said, but it did not specify where the products were manufactured.
When there were complaints for things like "fetal distress," "post-partum hemorrhaging," "shortness of breath" and an "unresponsive" patient, Ameridose didn't label them "adverse events" and its investigations didn't take into account the patient outcome, according to the FDA.
Besides tests of their potency, inspectors found that Ameridose "does not test final units of finished (products) for sterility and the presence of bacterial endotoxin."
In 53 cases in which "microbiological contamination (was) observed," the company "failed to investigate," the FDA said. Generally, inspectors faulted Ameridose for inadequate safeguards to prevent contamination, citing issues like gowns, gloves and glasses of personnel not being sterile and their foreheads being exposed.
The report - which the FDA said is comprised of "inspectional observations" but does "not represent a final agency determination" - also suggested problems at the facility itself. According to the report, Ameridose didn't do tests "after penetrating leaks were found;" some walls appeared to be "cracked, corroded and covered with what appeared to be adhesive material" in room where sterile drugs were prepared."
Inspectors faulted the facility's cleanliness as well, saying the "facility is not adequately designed and controlled to prevent (an) influx of contamination" and observing at least one bird and insects within 3 to 10 feet of what should have been sterile products.