FDA finds bugs, birds, failed 'event' follow-up during Ameridose inspection

Results of an inspection of a compounding pharmacy related to the one responsible for a meningitis outbreak found a long list of sterility issues that includes pipes leaking above a clean room and unresolved adverse event reports. The report of an inspection at Ameridose, which has common ownership with New England Compounding Center (NECC) was posted ahead of congressional hearings this week. It observed bugs and a bird flying around in the manufacturing plant. There were sterility problems and drug potency questions in which there was insufficient follow-up. It also was critical of the company not investigating adverse event reports. An earlier inspection at New England Compounding found similar problems. There a sample of 321 vials in a bin of methylprednisolone acetate that had been shipped to customers between Aug. 17 and Sept. 25, recorded 83 contained a "greenish, black foreign matter," while another 17 contained a "white filamentous material." The samples were of the drug suspected in the outbreak. FDA Commissioner Margaret Hamburg will testify before separate House and Senate committees this week to discuss the FDA's role, or lack of it, in the oversight of the plant. The agency found problems at NECC during a special inspection in 2006 but since oversight for compounders is generally handled by state authorities, there was no follow-up. There is a move afoot to give the FDA the power to oversee large compounders like NECC because of weak state regulation. The head of the Massachusetts pharmacy board was fired last week after it was learned that he had failed to seek an investigation of NECC ahead of the outbreak after authorities in Colorado expressed concern about it selling drugs there. There have been 32 deaths and more than 400 infections of fungal meningitis in patients who received injections of an NECC steroid. Inspection report | More