Massachusetts Company Linked to Outbreak Inspected in 2011

October 9, 2012

The specialty pharmacy that made the steroid suspected in a deadly meningitis outbreak was inspected and cleared by Massachusetts inspectors last year, state health officials said Thursday.

The inspection by the Department of Public Health was required after the New England Compounding Center in Framingham relocated its pharmacy on the same site, said Dr. Madeleine Biondolillo, director of the state’s Bureau of Healthcare Safety. The inspectors found no problems, she said.

The meningitis outbreak has sickened 35 people in six states, five of whom have died. All received steroid injections for back pain.

On Thursday, investigators were working to determine if a fungus found in a sealed vial at the New England Compounding Center was the same fungus blamed in the outbreak.

The company has voluntarily suspended operations and last week recalled 17,676 vials of the medication, an unknown number of which reached 75 clinics and other facilities in 23 states. None was distributed in Massachusetts.

As a precautionary measure, the Food and Drug Administration has suggested that medical professionals not use any company products.

“The fatalities and illnesses confirmed today by the CDC and FDA are tragic,” NECC said in a statement. “The thoughts and prayers of everyone employed by NECC are with those who have been affected.

A spokesman for the company said it was founded in 1998 and employs about 60 people.

Biondolillo said NECC has a pending complaint against it from this year, related to the potency of a medication used in eye surgery. It appears unrelated to the current outbreak, she said.

Biondolillo said two prior complaints, including one for sterile compounding procedures, were both resolved in 2006.

Compounding pharmacies custom-mix solutions, creams and other medications that generally aren’t commercially available in the form or the dose required.