http://www.bloomberg.com/news/2012-10-26/pharmacy-in-meningitis-outbreak-found-with-mold-bacteria.html

New England Compounding Pharmacy Inc., the company linked to a U.S. meningitis outbreak, discovered elevated levels of mold and bacteria at its drug- making facility in January and didn’t act, regulators said.

When the contamination was found to have exceeded limits the pharmacy itself set for mold and bacteria, “no documented corrective actions were taken,” the Food and Drug Administration said in a preliminary report that cites company documents. The FDA’s investigators uncovered tainted steroids and unsanitary conditions during inspections that began Oct. 1 at the facility in Framingham, Massachusetts, the agency said.

“It wouldn’t be proper for us to characterize this firm beyond the factual observations at this time,” Howard Sklamberg, the FDA’s deputy associate commissioner for regulatory affairs, said yesterday on a call with reporters. “This is part of an investigation. A broader investigation is where an agency characterizes and draws conclusions.”

The pharmacy suspended operations Oct. 3 after state and federal regulators began to link one of its steroid products, methylprednisolone acetate, to fungal meningitis infections that have now killed 25 people. The company, which used the name New England Compounding Center, recalled more than 17,000 doses of the steroid sold to at least 75 hospitals and clinics in 23 states. The government has said about 14,000 people received shots of the steroid, which is injected into the spinal cavity to relieve neck and back pain.