er, vents in the clean room covered with dirt and fuzz, and a metal
shelf in the same room covered in a reddish-brown, cloudy substance.
There was a greenish-yellow discoloration in one of the autoclaves and
condensation in another.
Board and FDA investigators discovered a similar scene at
Ameridose: contaminated hoods and rooms, insect infestations, even
birds flying through areas where sterile products were packaged and
stored. Tubs were positioned to catch rainwater that poured through
the roof above the clean rooms. Walls in a room used to prepare ster-
ile drug products were cracked, corroded and covered with a sticky
substance. Along with broken glass and foreign material, investigators
found a rainbow of colors in and around the sterile hoods: brownish
and whitish opaque structures, and thick residues that were orange,
brown and green.
According to an FDA report, Ameridose had failed to investigate at
least 53 instances of known microbiological contamination. In 2012
alone, 45 microbial and fungal colonies had been found in "critical
areas." Ameridose had taken no action.
There'd been at least 29 adverse reports, ranging from low potency
to postpartum hemorrhaging to oversedation to respiratory distress.
Ameridose had reported none of them, instead classifying them as
"patient responses" or "non complaints." The company hadn't tested
the potency of its final drug products before releasing them for distri-
bution, despite receiving 33 complaints about lack of effect.
On Sept. 26, at FDA's behest, NECC recalled the 3 suspect lots of
MPA. By then, however, about 14,000 doses had been administered. At
the Massachusetts pharmacy board's insistence, NECC surrendered
its pharmacy license and ceased production. At the end of October,
Ameridose also recalled all of its products. By that time it was selling
more than 2,200 drugs in syringes and IV bags.
1 6 2 • O U T PA T I E N T S U R G E R Y M A G A Z I N E • J U L Y 2 0 1 6
