FDA Releases NECC Report

The Form 483 posted by the agency covers five October inspections of the Framingham, Mass., compounding pharmacy.

Dated Oct. 27, the most recent CDC tally of cases linked to contaminated injectable steroids drugs made by the New England Compounding Center (NECC) lists 344 cases, mostly meningitis, in patients who underwent procedures in 18 states. The number of deaths has risen to 25.

The previous day, the U.S. Food and Drug Administration posted a copy of its Form 483 issued to NECC after five inspectors observed and later confirmed contaminated products in the cleanroom at NECC’s Framingham, Mass., facility.

As has been widely reported, the eight-page form lists several locations where bacteria and mold were found, and it states that NECC personnel said their practice was to turn off the air conditioning from 8 p.m. to 5:30 a.m. each night in the cleanroom. One vial of formulated preservative-free methylprednisolone acetate was lab-tested and found to be sterile in August 2012, but a second analysis of 50 1 mL filled vials confirmed viable microbial growth in all 50, according to the report.

"The investigators also observed problems with NECC's ability to maintain its cleanroom, which is the enclosed space that is designed and maintained to have a controlled environment with low levels of airborne particles and surface contamination. Production of sterile drug products in a properly functioning and maintained clean room reduces the risk of the introduction of microbial contamination into the drug during processing, including filling into its final container," FDA noted in its statement announcing the form had been posted. "The FDA issues a 483 at the end of an inspection when the investigators believe that they observed conditions or practices that, in their judgment, may indicate violations of the Federal Food, Drug, and Cosmetic Act, or related regulations. The 483 does not constitute a final FDA determination that any observation listed on the 483 is a violation of the Federal Food, Drug, and Cosmetic Act or any related regulations."

The agency said it considers the 483 along with any other relevant information when considering whether further action is appropriate. "The inspection report for NECC has not been completed and is not being shared at this time," its announcement stated.

FDA is working with CDC and state partners, including the Massachusetts Board of Registration in Pharmacy, to investigate the outbreak.

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