FDA finds contaminated vials, bacteria and mold at New England Compounding Center

The U.S. Food and Drug Administration Friday released a report of its observations from an inspection of the New England Compounding Center, the Framingham, Mass., facility tied to a nationwide fungal meningitis outbreak.

So far, 331 cases of fungal meningitis have been found in 18 states, including 25 deaths, according to the Centers for Disease Control and Prevention. The newest state to report an infection was South Carolina, and the latest death was reported in Tennessee. Seven other peripheral joint infections from injections given to joints such as the knees, hips, shoulders and elbows, have also been linked to the outbreak.

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During an FDA inspection of the facility on Oct. 2, 2012, investigators found 83 vials out of a bin containing 321 vials of preservative-free methylprednisolone acetate -- the injectable steroid tied to the outbreak -- contained a "greenish black foreign matter." Another 17 vials in the same bin contained a "white filamentous material." Fifty of the vials were sent by the FDA to a lab and tested, and all 50 confirmed the presence of microbial growth.

While the firm's worksheets said raw materials it used to manufacture drugs were sterile, the investigation notes the firm used non-sterile active ingredients, with the exception of sterile water, to formulate its preservative-free methylprednisolone acetate injections. The New England Compounding Center also provided no evidence to support the effectiveness of its steam autoclave used to ensure sterile materials, the report found.

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During an Oct. 4 investigation of the facility, the FDA found condensation and discoloration on the autoclave which had been used to sterilize the steroid injections as well as other drugs. That is the final sterilization step in the process for making these products, the FDA said.

Investigators also found a greenish yellow lining on the viewing lens of one of two autoclaves used to steam equipment. Condensation and discoloration was also observed on the other autoclave.

What's more, investigators found a parking area shared by a facility that recycles mattresses and plastics produced airborne dust particles 100 feet from the firm's HVAC system. Dark particulate along with white filamenteous substances were found covering the louvers of air conditioning behind the autoclave in the firm's middle room.

The CBS News Investigative team reported this week that there have been local complaints about the recycling center's smell and accumulation of debris outside the business. A large fire outside the recycling business in September 2009, captured in this YouTube video shows large clouds of black smoke billowing up from the back of the building that also held the compounding center.

During the course of its investigation, the FDA also observed different colored residues lining different weigh station hoods, which are used to weigh active ingredients and other raw materials used to make sterile drug preparations.

They also found issues in the firm's prep room, used to sterilize equipment before filling with drugs, including discoloration on surfaces and a leaky boiler and standing water approximately 30 feet from the entrance to the prep room. A mat at the entrance to the prep room was "brown and soiled."

The report also details "problems with NECC's ability to maintain its Clean Room" during the inspection. The clean room is an enclosed space that is designed and maintained to have a controlled environment with low humidity, proper temperature and low levels of airborne particles and surface contamination.

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Besides finding bacteria and mold on multiple surfaces locations in the clean room, the investigation noted the air conditioning in the clean room was turned off from 8:00 p.m. to 5:30 a.m. nightly.

Having the air conditioning turned off nightly "is not a typical practice for a clean room," Steven Lynn, director of the Office of Manufacturing and Product Quality, Office of Compliance, Center for Drug Evaluation and Research at the FDA, said during the press conference.

There was also presence of a dark, hair-like discoloration in a transition room between the clean room and where products are filled.

The report also shows tests of surfaces taken by the New England Compounding Center itself. While the company's own tests of equipment as far back as January 2012 indicated samples of bacteria and "overgrowth" of mold -- think of a plant growing out of control, the FDA said -- the agency did not find documentation of corrective actions taken by NECC to address the contamination.

The FDA notes these observations only reflect a "snapshot in time" and its investigation is not final. Massachusetts state health officials announced earlier this week plans to revoke the firm's license.

The FDA's "483" form that details its investigation can be found on its web site.

[marine1957]

"including 25 deaths"
These deaths should be enough to send the company's personnel, CEO on down, to life in prison.

[TheTexasBlonde]

Once again the FDA is investigating long after the horses have escaped from the barn. I do find it very disturbing some of the vials had contaminates that we visible to the naked eye. They did not need a microscope or even a magnifying glass to see the contaminates. What happened to this company's quality control department?

I get tired of the FDA finding violations in food or drugs well after the products have reached consumers which allows consumers to get sick or die.

[jakesnake_52]

What you don't know is that the Compounding Drug Industry is not regulated by the FDA but the State that it does business in. The FDA hs been attempting to regulate but the Industry has been successfully defending against it in Court and i Congress. Contact your Congress Representives and Senators and demand that they fight to get that Industry regulated by the FDA and not the States.

Also, since their license has now been permanently revoked, they are laying off their employees, preparing to file bankruptcy to protect themselves from the impact of a load of lawsuits. Their is a move to freeze the assets of the Company Officers (who by the way have bought a couple of personal properties worth over 2 million each in the past few months). It's also learned that the Company did not carry enough insurance.

All the FDA could do is write up some advisories about their inspections but they DID NOT have the authority to close em down or force them to comply. Apparently the State they're in did not want to do so either. So let's place the blame where it belongs, the Company, the State of Mass., the Congressman who fought against FDA enforcement and the Courts that supported the deregulation on the Federal level.

What we need is what's necessary to protect the consumer. But it would be against the notion of deregulation to help the job creators and protect the rich. I wonder if one of those purchased homes is worth the cost to all those lives. Wake up Tea Party! Start acting in the interests of everyone!!! not just an idealogy.

[alphaa10000]

IN THE PUBLIC INTEREST, BETTER REGULATION OF INDUSTRY

This story is yet another dramatic proof of the ever-present need for effective regulation of industry.

Those who cry about "over-regulation" should consider the consequences of failure to regulate properly.

Today, over 333 Americans with meningitis face those consequences daily. Another 25 people paid the ultimate penalty for presuming there was adequate regulation.