Federal inspectors find a multitude of problems at Ameridose, a major hospital drug supplier
In a report released Monday afternoon, federal inspectors detailed 15 problems found at major hospital drug supplier Ameridose LLC, ranging from insufficient testing of the sterility and potency of the drugs it made to the presence of vermin in an area where sterile products were packaged and stored.
Inspectors also wrote that the company didn’t adequately investigate instances when solutions used to manufacture drugs were determined to be potentially contaminated with unspecified microbes, the report said.
Ameridose, based in Westborough, is a sister company of New England Compounding Center, where contaminated batches of an injectable steroid have been linked to fungal infections that have sickened more than 400 people and killed 32. Ameridose agreed to recall all of its more than 2,000 products last month after the US Food and Drug Administration said it had not found “adequate assurance of sterility” during an inspection.
The 20-page report made public Monday describes the shortcomings identified during 14 days of investigation in October and November. They include concerns that the company failed to properly test batches of drugs, and problems with the validity of certain procedures used in sterility testing.
Investigators said Ameridose also did not adequately investigate 53 cases of microbial contamination found during testing of stock solutions, which are materials used to make drugs. Some lots of products were manufactured and released from the suspect stock solutions.
In another case, inspectors detailed specific sterility problems with stock solutions of sodium bicarbonate and hydromorphone.
“Sterility test positive results were routinely considered questionable by the laboratory, and re-testing was done without justification,” the inspectors wrote. “It is noteworthy that when further ... testing was done, the testing often revealed additional non-sterile units.”
Basic problems with sterility procedures were also identified. In one observation, inspectors noted that protective gowns, eye-protection, and gloves were not sterile. In another, they wrote that the sterility procedures had not been sufficiently validated.
Ventilation hoods used to prepare sterile drugs had “brownish structures, atypical in shape, upon the metal surfaces,” according to the report. Other hoods had deposits of orange, brown, and green residues within their intakes.
The inspectors also said the company did not respond to complaints from patients, a number of which were related to low potency of drugs.
In an e-mailed statement, a spokesman said the company had received the report and was preparing a response for the FDA.
“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 ... Ameridose is committed to addressing all observations in order to enhance our existing systems,” the statement said.
The continuing closure of Ameridose has put pressure on hospitals to find alternate sources of drugs. In this week’s newsletter of the Massachusetts Hospital Association, an article said that succinylcholine, used when doctors intubate patients, was in short supply because of the Ameridose recall.Carolyn Y. Johnson can be reached at firstname.lastname@example.org. Follow her on Twitter @carolynyjohnson.