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FDA Issues Investigation Report and Form 483 Showing NECC Contaminated Steroids and Improper Clean Room Linked to Deadly Fungal Meningitis Outbreak


 As of November 1, 2012, 386 cases of fungal meningitis have been reported to the CDC, including 28 deaths. These cases include 386 cases of fungal meningitis, stroke due to presumed fungal meningitis, or other central nervous system-related infection meeting the outbreak case definition, plus seven peripheral joint infections (e.g., knee, hip, shoulder, or elbow). No deaths have been associated with peripheral joint infections.

 

The CDC released a map of facilities that received preservative-free methylprednisolone acetate (80mg/ml) from the three implicated lots from New England Compounding Center (NECC) (Lot #08102012@51, BUD 2/6/2013) prior to their recall on September 26, 2012 (reported to you in the Oct. 15 Scalpel Weekly News). The map also includes a list of facilities by state including their contact information. Steroid injections from these lots from NECC are linked to the multistate outbreak of fungal meningitis and joint infections. The CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from the three implicated lots of methylprednisolone.

 

The FDA reported conditions observed at the NECC facility in Framingham, Massachusetts. The FDA released a copy of the FDA Form 483 issued to NECC. The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions in the clean room at NECC’s Framingham, Massachusetts, facility.

 

The investigators observed problems with NECC’s ability to maintain its clean room, 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.

 

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 FDA considers the 483 along with an Establishment Inspection Report (EIR), prepared by FDA investigators, and any other relevant information, including any responses received by the company. The agency then considers whether further action, if any, is appropriate. The inspection report for NECC has not been completed and is not being shared at this time.

 

Patients and clinicians need to remain vigilant for onset of symptoms because fungal infections can be slow to develop. In this outbreak symptoms typically have appeared one to four weeks following injection, but it’s important to know that longer and shorter periods of time between injection and onset of symptoms have been reported. Therefore, patients and physicians need to closely watch for symptoms for at least several months following the injection.

 

See the CDC Map of Facilities Receiving Recalled Steroids

 

See the FDA Announcement Regarding Form 483

 

See the FDA Form 483 Issued to NECC

 

See the CDC Report

 

See the FDA Update

 

See the Original Recall

 

 

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