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The FDA has released a report citing the conditions they observed at the New England Compounding Center, the compounding pharmacy who’s steroid products are linked to a multistate fungal meningitis outbreak.
The report cited finding unopened vials of preservative-free methylprednisolone during an inspetion on October 2nd that were observed to have `greenish black foreign matter’ and/or `white filamentous material’ inside.
Additional testing `confirmed the presence of viable microbial growth in 50/50 vials tested’.
It’s an 8-page report, and may be read in its entirety at this link. Here is the FDA press announcement.
FDA NEWS RELEASE
For Immediate Release: Oct. 26, 2012
Media Inquiries: Sarah Clark-Lynn, 301-796-9110, sarah.clark-lynn@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDAFDA reports conditions observed at New England Compounding Center facility
Today, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (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, Mass. facility.
The investigators also 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.
The FDA continues to work closely with the U.S. Centers for Disease Control and Prevention and state partners, including the Massachusetts Board of Registration in Pharmacy, to investigate the outbreak of fungal meningitis among patients who received NECC’s compounded preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid.
For more information:
- FDA Form 483 for New England Compounding Center
- FDA Form 483: Frequently Asked Questions
- FDA Inspections, Compliance, Enforcement, and Criminal Investigations
- Update on Fungal Meningitis
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