Vermin, insufficient testing found in Ameridose inspection
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 did not adequately investigate instances when solutions used to manufacture drugs were determined to be potentially contaminated with 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.
FDA spokeswoman Sarah Clark-Lynn said she could not comment on how serious the findings are, and noted that no infections have been linked to Ameridose products.
“What I can tell you is that FDA inspectors observed conditions and practices at Ameridose which demonstrated that the firm could not consistently assure that their injectable products were sterile and safe for use by patients,” Clark-Lynn wrote in an e-mail. She said the company failed to “test finished product for potency, failed to investigate complaints for ineffective products, failed to investigate violations of their own environmental sampling plan, and fails to adequately maintain equipment and facilities used to manufacture sterile drug products.”
In an statement, an Ameridose spokesman said the company had received the report and was preparing a response for the FDA. Ameridose agreed with state regulators to suspend operations on Oct. 10 and is scheduled to remain closed until Nov. 19. Last week, it laid off 650 people, most of its workforce.
“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.
Among the problems outlined by investigators were that Ameridose did not adequately investigate 53 cases of microbial contamination found during testing of stock solutions, which are materials used to make drugs. Some sterile injectable drug products were manufactured from the suspect stock solutions and released, according to the report.
In another case, inspectors described 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.
The inspectors also said the company did not respond to complaints from patients, some of which were related to low potency or ineffective drugs.
Tony Chen, chief executive of FDAzilla, a company that provides businesses with information about the FDA, said there were several unusual aspects of the Ameridose report, called a 483.
Chen said that his company’s analysis of more than 800 such forms found the average number of investigators on such inspections is fewer than two people and there are typically about five or six observations of conditions that may violate federal law. There are 17 investigators and microbiologists listed on the Ameridose form 483. He also noted there were two issues that were flagged as repeat violations — issues that had also been reported after a 2008 inspection.
The continuing closure of Ameridose has put pressure on hospitals to find alternate sources of drugs.