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A series of inspections conducted in October at the New England Compounding Center – the facility at the heart of the investigation into a recent fungal meningitis outbreak – found nonsterile conditions and contaminated vials of the steroid methylprednisolone acetate.
Investigators with the Food and Drug Administration’s New England District Office visited the New England Compounding Center (NECC) facility in Framingham, Mass., during 7 days in October. The FDA released the observations from those inspections on Oct. 26.
On Oct. 2, the FDA investigators noticed what appeared to be "greenish-black foreign matter" in 83 vials of methylprednisolone acetate and "white filamentous material" among another 17 vials from the same bin. The vials were marked with the same lot number as a shipment that was sent to customers in August and September. Although a sample taken by the company in August found that lot of vials to be to be sterile, the FDA’s own laboratory analysis found the presence of viable microbial growth in 50 of the 50 unopened vials it tested.
The investigators also discovered problems in the NECC’s clean rooms, which are enclosed spaces used to help reduce the risk of microbial contamination when processing sterile drug products. For instance, the firm’s own environmental monitoring reports revealed that between January and September 2012, there was bacteria and mold in multiple locations, including on surfaces within the clean rooms. There was no documentation that the company attempted to correct these problem, even though the contamination was above acceptable limits, according to the FDA.
FDA officials refused to characterize the observations made by its investigators or to comment on any other details of the agency’s ongoing investigation of the NECC.
A series of inspections conducted in October at the New England Compounding Center – the facility at the heart of the investigation into a recent fungal meningitis outbreak – found nonsterile conditions and contaminated vials of the steroid methylprednisolone acetate.
Investigators with the Food and Drug Administration’s New England District Office visited the New England Compounding Center (NECC) facility in Framingham, Mass., during 7 days in October. The FDA released the observations from those inspections on Oct. 26.
On Oct. 2, the FDA investigators noticed what appeared to be "greenish-black foreign matter" in 83 vials of methylprednisolone acetate and "white filamentous material" among another 17 vials from the same bin. The vials were marked with the same lot number as a shipment that was sent to customers in August and September. Although a sample taken by the company in August found that lot of vials to be to be sterile, the FDA’s own laboratory analysis found the presence of viable microbial growth in 50 of the 50 unopened vials it tested.
The investigators also discovered problems in the NECC’s clean rooms, which are enclosed spaces used to help reduce the risk of microbial contamination when processing sterile drug products. For instance, the firm’s own environmental monitoring reports revealed that between January and September 2012, there was bacteria and mold in multiple locations, including on surfaces within the clean rooms. There was no documentation that the company attempted to correct these problem, even though the contamination was above acceptable limits, according to the FDA.
FDA officials refused to characterize the observations made by its investigators or to comment on any other details of the agency’s ongoing investigation of the NECC.
A series of inspections conducted in October at the New England Compounding Center – the facility at the heart of the investigation into a recent fungal meningitis outbreak – found nonsterile conditions and contaminated vials of the steroid methylprednisolone acetate.
Investigators with the Food and Drug Administration’s New England District Office visited the New England Compounding Center (NECC) facility in Framingham, Mass., during 7 days in October. The FDA released the observations from those inspections on Oct. 26.
On Oct. 2, the FDA investigators noticed what appeared to be "greenish-black foreign matter" in 83 vials of methylprednisolone acetate and "white filamentous material" among another 17 vials from the same bin. The vials were marked with the same lot number as a shipment that was sent to customers in August and September. Although a sample taken by the company in August found that lot of vials to be to be sterile, the FDA’s own laboratory analysis found the presence of viable microbial growth in 50 of the 50 unopened vials it tested.
The investigators also discovered problems in the NECC’s clean rooms, which are enclosed spaces used to help reduce the risk of microbial contamination when processing sterile drug products. For instance, the firm’s own environmental monitoring reports revealed that between January and September 2012, there was bacteria and mold in multiple locations, including on surfaces within the clean rooms. There was no documentation that the company attempted to correct these problem, even though the contamination was above acceptable limits, according to the FDA.
FDA officials refused to characterize the observations made by its investigators or to comment on any other details of the agency’s ongoing investigation of the NECC.
