Oct. 26, 2012 at 2:01 PM ET
Updated, 10/27: Six new cases of fungal meningitis have been reported in the outbreak linked to steroid injections manufactured by a Massachusetts pharmacy, the Centers for Disease Control and Prevention reported Saturday, bringing the total to 344 cases of infection in 18 states and 25 deaths.
Original: Federal health inspectors found "greenish black foreign matter" growing in dozens of vials of supposedly sterile drugs linked to a deadly outbreak of fungal meningitis at a Massachusetts pharmacy, plus evidence of bacteria and mold throughout the site, newly released documents show.
When officials later tested 50 of those vials, they found that all 50 were contaminated.
Contamination throughout the facility was documented by the company itself as far back as January and through September, a new report from the Food and Drug Administration found. In some cases surfaces were overgrown with visible mold.
Although documentation by the New England Compounding Center of Framingham, Mass., stated that the raw materials used to make epidural steroid pain injections were sterile, there was no evidence that that was actually the case, according to FDA inspectors who visited the plant on Oct. 1 and 2, Oct. 9, Oct. 15 and Oct. 23.
That's all according to the release Friday of inspection documents tied to the outbreak. On Saturday, the CDC said 337 people developed fungal meningitis, had strokes or other central-nervous system infections, while seven developed infections after injections in joints such as hips, elbows and knees.
In addition, the equipment used for steam sterilization, an autoclave, was tarnished with "greenish-yellow discoloration" and a leaking boiler just outside a clean room created wet floors soiled with "thick white debris" and "thick, black granular material."
NECC was "unable to demonstrate" that the autoclave was capable of sterilizing the drugs, said Steven Lynn, director of the FDA's Office of Manufacturing and Product Quality. In addition, there were several problems with maintenance of the company's clean room. For instance, the company turned off the air conditioning used for temperature control at night, which is not standard practice.
"In a properly functioning clean room, it reduces the risk of contamination," Lynn said.
The federal inspectors' results mirror those released earlier this week by the Massachusetts Department of Public Health. Officials there said the NECC violated regulations by distributing large batches of sterilized drugs for general use rather than requiring individual patient prescriptions as required under terms governing compounding pharmacies.
In addition, inspectors said the firm released two lots of the recalled steroid drugs before receiving results of sterility testing. NECC also failed to follow proper standards for autoclaving, or sterilizing drugs using high pressure steam. In particular, inspectors said, the firm did not keep products in the autoclave for the minimum 20 minutes required to ensure sterility.
In addition, inspectors found a leaking boiler outside the firm's "clean room" that created an environment ripe for the growth of mold or other contaminants. And, they found floor mats visibly soiled with debris outside the clean room door.
The FDA observed the greenish-black contamination in 83 vials of a bin of 321 vials of methylprednisolone, the steroid tied to the growing outbreak. Seventeen vials appeared to contain "white filamentous material."
FDA officials noted that the inspection document is a snapshot in time and the investigation is continuing.
For more information, including a list of health care facilities that received vials from NECC, go CDC.gov