bacteria colonies were
found on one wall and
3 on another. Twelve
colonies of bacteria
resided on a shopping
cart handle. There
were 13 blooms of fun-
gus on one area of the
floor and 15 on anoth-
er.
Beginning in January 2012, NECC's surface and air sampling of the
Clean Room 1 suite of rooms produced alarming results. The air, the
surfaces and samples of the glove fingertips of compounding person-
nel and even the gloves in the glove box cultured positive for bacteria
and mold. The results would persist for 37 weeks. NECC never inves-
tigated and never stopped production.
According to the indictment, in May the Massachusetts Board of
Pharmacy once again launched an investigation. NECC had made a
hyaluronidase-lidocaine preparation for the famed Massachusetts Eye
and Ear Infirmary for retrobulbar blocks during cataract surgery.
Unfortunately, the medication contained little or no anesthetic, so
patients experienced intense pain. Now the Board was asking NECC
for the individual patient prescriptions. In a panicked e-mail to Greg,
Mr. Cadden wrote that all the syringes were dispensed without a pre-
scription. Greg wrote back, instructing Mr. Cadden to "call [Mass Eye
and Ear] and ask nonchalantly for a patient roster for the 170 syringes
and ask where all the rest of the syringes are." Mr. Cadden: "I will try
but unless she is dumb she will smell a skunk."
Mr. Cadden e-mailed Greg a prescription template and a list of
patients the hospital had identified. Greg told his staff to make 300
J U L Y 2 0 1 6 • O U T PA T I E N TS U R G E R Y. N E T • 1 5 9
FDA
officials
reacted
as
though
Ameridose
was
a
nuisance
it
could
not
figure
out
how
to
resolve,
rather
than
a
ticking
time
bomb,
says
a
government
report.
