and Sphingomons paucimobilis, according to FDA inspection
reports. The beta meth asone turned out to be underpowered, and test-
ed positive for endotoxin. One patient who received tainted methyl-
prednisone, William Koch, died 2 years later. NECC never admitted
liability. The company settled out of court with his widow in 2007.
Terms were not disclosed.
The FDA inspections that followed revealed that NECC was a com-
plete mess. Inspectors found that the company had no way of reliably
compounding suspensions at the right strength. The firm's ability to
preserve the sterility of its medications was highly questionable.
Inspectors identified 13 areas where NECC was risking sterility and
improper formulations. There was no assurance that the equipment
and workspaces were clean, no environmental monitoring of the clean
room and many more concerns. NECC had purchased a standard oper-
ating procedure manual from a consultant, but the manual wasn't cus-
tomized to NECC — and NECC wasn't following it anyway. NECC also
did not maintain formal customer complaint files. It had no way of
investigating errors when things went wrong.
When the inspectors asked Mr. Cadden about the tainted betametha-
sone, he at first claimed that the drug wasn't made at NECC, accord-
ing to their report. They found the suspect lot on a computer printout.
Also, the health professional who had reported the incident said he
had spoken to Mr. Cadden about it personally.
The FDA report seemed to indicate that Mr. Cadden had a deep
misunderstanding of how sterility worked. He admitted to investiga-
tors that another batch of "sterile" betamethasone had come back
positive for endotoxin. He said he changed the suspending agent,
made another batch and then covered the beaker with aluminum foil
while awaiting the lab results. It could take from 7 to 10 days, he
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