UPDATE 2-FDA: Pharmacy co. in meningitis crisis saw contaminants
By David Morgan
WASHINGTON Oct 26 (Reuters) - 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 officials.
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 report said.
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 Product Quality.
"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 system.
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