FDA inspections of the New England Compounding Center (NECC) facility in Framingham, MA, found unsanitary conditions throughout the facility, including rooms where methylprednisolone acetate was made. Three lots of the drug have been implicated in a fungal meningitis outbreak that has over 300 confirmed cases. Over 20 people have died. Attorney Fred Pritzker has filed a lawsuit against NECC and is preparing several additional lawsuits against NECC, clinics where NECC shots of methylprednisolone were administered, and others. Contact Fred for a free consultation here.
During its inspection of the NECC facility, FDA found NECC documents showing that NECC employees had found mold and bacteria in numerous locations at the NECC compounding facility, including in the main clean room, the gown room, and the prep room, throughout 2012. Although these contaminants were found by NECC, FDA found no evidence that the company tried to resolve the problem or did additional testing of product to ensure sterility.
Moreover, FDA found contaminated vials of one lot of methylprednisolone acetate implicated in the outbreak:
On 10/02.2012, we observed approximately eighty-three (83) vials our of bin containing 321 vials of methylprednisolone acetate (preservative free) 80mg/mL from lot #08102012@51 (shipped to customers between 8/17/12 – 9/25/12 per firm distribution data), a sterile injectable drun, to contain what appeared to be greenish black foreign matter. Seventeen (17) vials from the same bin of methylprednisolone acetate (preservative free) 80mg/mL were observed to contain what appeared to be white filamentous material.
FDA testing and analysis of some of these vials of methylprednisolone acetate (preservative free), confirmed the presence of viable microbial growth in all of the vials tested (50/50). One vial examined microscopically showed fungal morphological features. Somehow, though NECC testing of the same lot of methylprednisolone acetate (preservative free) were negative for any contamination.
Although the NECC formula worksheets state the raw materials used to make methylprednisolone acetate were sterile, the Pharmacy Director stated that the firm uses non-sterile injectable suspensions including but not limited to preservative free methylpredisolone acetate and triamcinolone. Also, during the inspection, FDA observed that the labeling for the methylprednisolone API and additional raw materials did not indicate that they were sterile. In addition, NECC provided no documentation or evidence to support that the steam autoclave cycle used to sterilize suspensions formulated using non-sterile API and raw materials is effective.
Mold and bacteria were found in numerous locations at the NECC compounding facility, including in the main clean room, the gown room, and the prep room.
During the FDA inspection on October 2 and 4, 2012, FDA found the following:
- Greenish yelow discoloration lining the interior surface of the viewing lens within the “Inside” autoclave, one of two tabletop autoclaves used for steam sterilization of various components and equipment used in the formulation of sterile drug products;
- Tarnished discoloration and condensation on the interior surfaces of the “Outside” autoclave, one of two autoclaves used for steam sterilization of various components and equipment used in the formulation of sterile drug products;
- What appeared to be dark particulate and white, filamentous substances covering the louvers of an HVAC return located behind one autoclave used for steam sterilization of formulated bulk drug suspensions, including preservative free formulations of methylprednisolone and triamcinolone, which are intended for injection;
- Yellowish residue lining the rear return of equipment used to weigh active ingredients and other raw materials utilized in the formulation of sterile drug preparations;
- Greenish residue covering the ceiling of equipment used to weigh active ingredients and other raw materials utilized in the formulation of sterile drug preparations;
- Tarnished discoloration on equipment in the prep room used for formulation of sterile drug products;
- A boiler leaking water into puddles and wet floor surfaces around the boiler that appeared to be soiled with thick white debris and thick black granular material;
- Gaps between the closed sliding door between the warehouse and the prep room;
- A brown and soiled tacky mat located within the entrance of the prep room; and
- A cloudy discoloration, reddish-brown cloudy substances dark, hair-like discoloration in a “Clean Room” on metal surfaces used to formulate and fill sterile preparations, including methylprednisolone.
Contact Attorney Fred Pritzker here for a free consultation here regarding a meningitis lawsuit. He and his Bad Bug Law Team are representing people with confirmed cases of fungal meningitis (Aspergillus and Exserohium), patients who have suspected cases of meningitis, and patients who do not have meningitis but had a spinal tap (lumbar puncture) to test for meningitis.