Federal regulators warned a major drug manufacturer about problems, including a disturbing issue involving bugs in vials of sterile medications, said MSNBC. But, in an odd move that some are questioning, the warning came on the same day health officials allowed the same drug maker to increase production of a limited drug for children with cancer.
Officials with the U.S. Food and Drug Administration (FDA) has issued a warning letter to APP Pharmaceuticals LLC of Schaumberg, Illinois, concerning a variety of issues they have with the company.
The letter cited violations at a New York plant such as insects found in “clean rooms” and in vials of drugs that had been distributed, as well as APP’s failure to report defects, including vials contaminated with glass and other foreign matter; problems documenting sterile technique; and marketing unapproved drugs, wrote MSNBC. “It is apparent that APP Pharmaceuticals LLC’s has failed to implement global corrective actions,” the letter said.
“You continued to find insects in your manufacturing area, in finished product (two vials), and you received a complaint for an insect in a distributed vial,” said the letter sent by Ronald M. Pace, director of the FDA’s New York district, according to MSNBC.
Company officials told FDA inspectors the root cause of the bug problem was with the firm’s supplier of gowns, but they had not scheduled an audit of the firm until six months later, December 2011, the warning said.
The FDA also said the APP neglected to fully investigate customer complaints, such as one “on March 1, 2010, citing dark particulate matter in a vial of Heparin,” reported FiercePharma. Reports of vials missing labels and other issues were also discussed in the letter, said FiercePharma.
The letter written on February 22, was the same day APP made an announcement it received accelerated FDA approval to market preservative-free methotrexate in response to a serious shortage of the childhood leukemia medication, said MSNBC. FDA and oncologists said methotrexate was so limited that hospitals could use all their supplies within a matter of weeks. This was in early February. The drug is considered a life-saving therapy for children suffering from acute lymphoblastic leukemia (ALL), among other patients and illnesses, explained MSNBC.
But, apparently the 2 issues are not related.
“Methotrexate is not manufactured at the Grand Island plant and, thus, is absolutely unaffected from the warning letter,” Matthias Link, a company spokesman, wrote in an e-mail to msnbc.com.
“We take all the issues listed in the warning letter very seriously and we are committed to promptly addressing these,” he wrote.
Erin Fox, manager of the Drug Information Service at the University of Utah, which tracks the nation’s drug shortages, said “Balancing the demand for life-saving drugs with the demand that those drugs be safe and sterile is an ongoing challenge.”
“Between the shortages and the quality issues, it is difficult to have any kind of confidence in our drug supply,” she said.
APP has 15 days from the date of the letter to respond to the problems and explain how bugs ended up in an aseptic “clean” room in which critical drugs are produced.
APP Pharmaceuticals is a subsidiary of Fresenius Kabi Pharmaceuticals Holding Inc. of Germany.