The FDA issued a report on October 26, 2012 regarding its inspection of the facilities of the New England Compounding Center (NECC) that took place on October 1-2, 4-5, 9, 15, and 26, 2012, and the reported observations are disturbing. NECC is at the center of the recent fungal meningitis outbreak in the United States in which contaminated vials of NECC’s epidural steroid injections have been associated with patients who subsequently developed fungal meningitis, with some of them dying from their conditions.
During the October 2, 2012 inspection, the FDA inspectors observed approximately 83 vials in a bin containing 321 vials of the sterile injectable drug methylprednisolone acetate (preservative free) 80 mg/mL with what they described as “greenish brown foreign matter” and 17 vials from the same bin containing “white filamentous material.” The 321 vials were part of a lot that were shipped to customers between August 17, 2012 and September 25, 2012. NECC reported that it had tested the sterility of a bulk sample from the same lot that it determined to be “sterile” but the FDA’s testing of vials from the same lot found in 50 of 50 vials tested that the contents had the presence of “viable microbial growth” and one of the tested vials showed “fungal morphological features.”
While NECC’s formula worksheets state that the raw materials used in production are sterile, NECC’S Pharmacy Director advised the FDA inspectors that non sterile active pharmaceutical ingredients and raw materials were used in the production of preservative free methylprednisolone acetate and another of NEC’s products, triamcinolone.
The FDA inspectors reported that NECC’s environmental monitoring program found bacteria and mold within NECC’s Clean Room 1 and Clean Room 2 where production of sterile drugs took place between January 2012 and September 2012 (NECC turned off the air conditioning in the Clean Rooms each night between 8:00 p.m. and 5:30 a.m.). The FDA found that NECC did not investigate when limits exceeded their action limits and NECC did not identify the isolates. The FDA further found that NECC had not documented corrective actions to remove the bacterial and mold contamination from NECC’s facility.
On October 4, 2012, the FDA investigators observed condensation and what they considered to be tarnished discoloration on the interior surfaces of an autoclave that uses steam during the final sterilization step for bulk drug suspensions that include the preservative free formulations of methylprednisolone acetate and triamcinolone. Another autoclave that was used to sterilize different sizes of vials and stoppers used to produce sterile drug products was observed to have greenish yellow discoloration on the interior surface of the viewing lens. Another autoclave was observed to have similar problems.
The FDA report noted that NECC’s facility is located next to a recycling facility that recycles mattresses and plastics, the operation of which was producing airborne particulates within approximately 100 feet of NECC’s rooftop HVAC systems. The FDA inspectors noted residue on HVAC returns in various areas and on various equipment in NECC’s facility.
The FDA report also noted the inspectors’ observation of a leaking boiler near a prep room that was leaking water into puddles and that the wet floor around the boiler appeared to be soiled with thick white debris and thick black granular material. Also observed were gaps in the sliding doors between the prep room and the warehouse, even when the doors were fully closed. Other observations of apparent discoloration issues were contained in the FDA’s report.
To read the FDA’s report in its entirety, click here.
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