Bacteria, Bugs and a Bird: FDA Reports Findings at Ameridose
Sister company's review echoes findings at New England Compounding Center
Published: November 14, 2012
If you thought conditions at New England Compounding Center were bad, the FDA report on sister company Ameridose may just top it. Ameridose has been shut down since Oct. 22 and, on Oct. 31, recalled all its products while the FDA investigation continued. Now, 20 pages of results are in, and these selections speak for themselves:
- Ameridose failed to follow up in at least 53 instances of "microbiological contamination" noted during "sterility testing of sterile stock solutions intended to be used in the manufacture of sterile injectable drug products.
- At least 1 bird was observed flying in an area where sterile finished products were packaged and stored.
- Insects were observed in the same area as the bird, and were within approximately 3 to 10 feet of the controlled area where sterile products were manufactured.
- Environmental monitoring of some hoods was not performed, and sterile drug products were "aseptically manipulated in these hoods as part of daily operations."
- Staff did not use sterile gowns, eye protection or gloves, and had exposed foreheads when working inside the open-faced hoods to make sterile injectables.
The FDA's report on NECC was mentioned many times over the course of a hearing on the fungal meningitis outbreak — which has killed 32 and infected 438 — by the House Energy and Commerce Committee's Oversight and Investigations Subcommittee.
Rep. Cliff Stearns (R-Fla.), the subcommittee chair, and Rep. Diana DeGette (D-Colo.) attempted to question Barry Cadden, RPh, co-owner and managing pharmacist of NECC. However, Mr. Cadden, reading off an index card, repeatedly invoked his right under the Fifth Amendment to not answer any questions, including whether he was going to continue to invoke the Fifth Amendment to avoid answering the subcommittee's questions.
Mr. Cadden was dismissed by Rep. Stearns, and the focus of the hearing turned toward the FDA's and Massachusetts's oversight of NECC in specific and compounding pharmacies in general. Questions from subcommittee members centered on the current laws in place, whether new legislation is needed, why the outbreak happened and why NECC hadn't been shut down after warnings in the past. More testimony and information can be found here.
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