happened.
The hits kept com-
ing. In 2009, FDA
received an anony-
mous e-mail from a
company informant:
"(When) the FDA
came to Ameridose …
for an inspection…the
company performed
illegal and unethical
actions. They directed the testing facilities they use to change reports,
based on the drug results. They forged documents, forced employees
to direct others to do so." The informant implicated Greg Conigliaro.
In 2010, an Ameridose pharmacist warned FDA of contamination
issues. He said in a recent batch of succinylcholine, particulates includ-
ing "angel hair" and pieces of the bag itself appeared in the solution.
He said that the quality assurance program had been downsized and
deprioritized. He said the Ameridose sales team was "assisting in label-
ing operations in a clean room" and that 1 of the 3 clean rooms had
tested positive for mold. He said Ameridose rigged tests by cleaning
the area first, then taking environmental samples. He said "when pack-
ages are dropped on the floor, employees are told to pick up and ship"
and that bubble wrap is stored on the floor of a room that is "dirty and
never cleaned."
During the same period, FDA received a report about a nurse
administering half of a syringe of dextrose 50% made by Ameridose
to a patient before noticing "a white precipitate below the rubber
plunger."
In February 2011, during a shortage of sodium chloride, a pharma-
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 3
• SOUND OF SILENCE New England Compounding Center President Barry Cadden told lawmakers at a congressional
committee that he would use his Fifth Amendment right to not answer questions in order to avoid self-incrimination.
AP
Photo
