F.D.A. Finds Unsanitary Conditions at New England Compounding Center
Investigators from the Food and Drug Administration said Friday that they had found problems in the maintenance of the clean room where drugs were manufactured at the New England Compounding Center, the pharmacy whose tainted medicine for neck and back pain caused a national meningitis outbreak that has claimed 25 lives and infected more than 300 people in 18 states.
The F.D.A.’s eight- page report on its inspection of the company’s premises, posted on the agency’s Web site, noted that the Massachusetts-based company’s own sampling in the last several months had found evidence of bacteria or mold at various places in the factory, in some cases exceeding levels that required action.
“There was no investigation conducted by the firm when levels exceeded their action limits and there was no identification of the isolates,” the F.D.A. inspectors wrote. “No documented corrective actions were taken to remove the microbial contamination (bacteria and mold) from the facility.”
The report also said that pieces of equipment used to weigh active ingredients in drugs were coated with a greenish and yellowish residue.
The national meningitis outbreak, one of the biggest drug safety disasters since 1938, has prompted calls in Congress for legislation to strengthen the F.D.A.’s ability to regulate compounding pharmacies, though some critics of the agency have insisted it already had sufficient authority to have acted more forcefully.