FDA Says Pharmacy Tied To Fatal Meningitis Did Not Maintain "Clean Rooms" reports Arden

(EstateNewsWire.com, November 11, 2012 ) Victoria, Australia -- The Massachusetts compounding pharmacy whose injectable drugs have been linked to a deadly outbreak of fungal meningitis apparently knew over a nine-month period its supposedly sterile “clean rooms” were contaminated by bacteria and mold, but did nothing to fix the problem.

The outbreak has thus far surfaced in 19 states, killing 28 and strickening over 360 with sickness, according to the Centers for Disease Control and Prevention. Health officials say tainted drugs may have exposed about 14,000 people to the rare, non-contagious form of the disease, which attacks linings covering the spine and brain.

A preliminary U.S. Food and Drug Administration report says bacteria and mold were detected on surfaces of the New England Compounding Center’s “clean rooms,” where the drugs were processed and packaged into containers. Even though NECC’s own monitoring reported nearly 50 cases of possible bacteria and mold contamination between January and September 2012, the company apparently took no steps to fix the problem.

The FDA report, known as Form 483, gives investigators’ post-inspection observations of practices and conditions they view as violating FDA rules. The report listed three contaminated lots of methylprednisolone acetate. The compound is a steroid typically injected into patients’ spine or joints to treat chronic pain. About 17,000 vials of the drug from the contaminated lots were shipped to pain clinics in 23 states.

About 100 sealed vials in one lot were found to be contaminated with a greenish-black mold visible to the naked eye. Microscopic examination identified the mold as the same found in many of the fungal meningitis patients.

The FDA report also noted that although strict standards govern temperature and humidity in “clean rooms,” NECC also routinely shut off the air conditioning overnight in at least one “clean room.” The report also found a “greenish yellow discoloration” inside sterilizing equipment. There was also a dark discoloration on the wall of a supposedly sterile room, and standing water from a leaking boiler about 30 feet away from where the product was prepared. The FDA notes statements on its Form 483 reports are not final agency determinations; a federal-state probe of NECC is continuing.

Compounding pharmacies are supposed to be small-scale specialty operations making hard-to-locate drugs for local doctors and patients who cannot tolerate mass-produced drugs. They have not been subject to the same oversight FDA gives ordinary drug makers, but some in Congress say the meningitis outbreak shows greater controls are needed.

The Massachusetts Board of Pharmacy has permanently revoked NECC’s license, and those for the company’s three main pharmacists, and state health officials said they have begun a criminal investigation.

About Arden.com.au:

Arden.com.au (http://www.arden.com.au) is located in Dandenong, South Victoria, with a new branch office in Queensland, Ardenthe and is an industry leader in manufacturing, installing and supplying clean rooms and spray booths throughout Australia and New Zealand. Arden’s experienced staff have over 35 years working on customized clean room and spray bath construction, which can be found at the Arden website.

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