By David Morgan
WASHINGTON Oct 26 The pharmacy company at the
center of a deadly meningitis outbreak knew of contamination at
its Framingham, Mass., facility as early as January but has no
record of acting to safeguard the drugs prepared there, U.S.
health officials said on Friday.
A report by the Food and Drug Administration showed that
internal monitoring at the New England Compounding Center had
repeatedly detected bacterial and mold contaminations in the
months before the first suspect shipments of injectable steroid
treatments left the production site in May.
NECC said in a statement that it had received a copy of the
report and would provide comments to health officials after
reviewing the document.
The report, known as an FDA Form 483, contained findings
collected by NECC's environmental monitoring program from
January to September, as well as observations from several
October inspections conducted by FDA and Massachusetts state
Three lots of NECC preservative-free methylprednisolone
acetate for back and joint pain have been linked to a national
outbreak of rare fungal meningitis. The U.S. Centers for Disease
Control and Prevention said on Friday that 331 cases, including
25 deaths, in 18 states had been reported.
The FDA's report adds to an emerging picture of sanitary
conditions at NECC, a matter of interest to U.S. and state
investigators trying to determine why the pharmacy was allowed
to operate despite problems going as far back as 2002.
Massachusetts health regulators said earlier this week that
they had found evidence of problematic procedures,
record-keeping and work conditions inside the pharmacy facility.
FDA CITES COMPANY RECORDS
According to the FDA report, company records showed more
than four dozen instances of bacterial or mold contamination
that exceeded acceptable levels over an eight-month period. Some
of the contamination occurred inside two "clean rooms."
The report quoted NECC personnel as saying the firm shut off
clean room air-conditioning each night at 8 p.m., a routine that
FDA officials said was not typical for a facility that needs to
be kept at a steady temperature.
A number of instances involved "over-growths," or blooms of
bacteria or mold visible to the naked eye.
The FDA said the discoveries were not investigated, the
contaminants were not identified, and sterile products made on
the days when samples were taken were not inspected. NECC had no
evidence that corrective actions were taken, according to the
In a teleconference with reporters, FDA officials strictly
limited their remarks to the observations contained in the
report. They acknowledged that companies are responsible for
correcting contamination that exceeds "action levels."
"Manufacturers and compounding firms know what to do," said
Steven Lynn, director of the FDA's Office of Manufacturing and
"They have the responsibility to manufacturer quality drugs
and to have processes in place to ensure that there's no
breakdown in the supply or the processes that would cause
contamination," he told reporters in a teleconference.
The FDA said its own inspections found "greenish black
foreign matter" and other contaminants in an injectable steroid,
17 vials of steroids containing a "white filamentous material."
According to the report, officials found microbial growth in
50 of 50 vials tested, tarnished discoloration on the internal
services of sterilizing equipment and yellow residue on
equipment used to weigh ingredients and other raw materials used
to create sterile drugs.
The FDA said the production site abuts a recycling facility
that handles mattresses and plastics, where excavators and
freight trucks produce dust about 100 feet from rooftop units
that serve NECC's heating, ventilation and air conditioning