FDA Inspectors Find Mold, Bacteria and Bugs at Ameridose

FDA Inspectors Find Mold, Bacteria and Bugs at Ameridose

An FDA test for mold at the New England Compounding Center, sister company of Ameridose.

The Food and Drug Administration has released a scathing report on poor sanitary conditions and a lack of quality control at Ameridose, the sister company of the Massachusetts compounding pharmacy linked to a deadly outbreak of fungal meningitis. FDA inspectors found cracked and corroded walls, mold, bacteria, insects, and even a live bird at the Ameridose facility in Westborough, Massachusetts.

Last month Ameridose voluntarily recalled all of its drug products, including many pain medications, after the FDA raised concerns about a “lack of sterility assurance” at the facility. Ameridose has the same owners as the New England Compounding Center (NECC), which produced and distributed a contaminated steroid blamed for the deaths of 32 pain patients.

The Ameridose recall includes thousands of painkillers and other drugs that Ameridose shipped to hospitals and health care providers around the country.

FDA inspectors say Ameridose failed to adequately investigate adverse events reported by patients who used its products. At least one patient was reported to have a “life threatening” event after using heparin, an anti-coagulant used during surgery and to treat heart patients. Five cases of postpartum hemorrhaging and one case of fetal distress were reported in patients given oxytocin, which is used to induce labor.

The FDA report says many of these reports were ignored by Ameridose or dismissed with “vague, canned language.”

The inspectors also observed insects and “at least one bird was observed flying” in a building where sterile drugs are packaged and stored.

“Your firm failed to investigate microbiological contamination observed at least fifty three (53) times noted during sterility testing of sterile stock solutions intended to be used in the manufacture of sterile injectable drug products, including lots of Fentanyl, Ropivacaine, Morphine, etc.,” the FDA report said.

Other incidents included dozens of complaints about ephedrine, fentanyl, oxytocin and other drugs failing to have any effect. The FDA said the drugs were not tested for potency prior to being distributed to customers.

Ameridose said it was still evaluating the FDA report.

“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,” the company said in a statement. “Ameridose is committed to addressing all observations in order to enhance our existing systems.”

Ameridose and NECC are both owned by Greg Conigliaro and Barry Cadden. FDA inspectors have found similar sanitary problems at NECC.

The FDA report came as Congress prepares to holding hearings on the regulation of compounding pharmacies. The FDA has been under fire for leaving too much regulatory enforcement of compounders to state and local agencies.

Authored by: Pat Anson, Editor