This past Friday, October 26, 2012, the U.S. Food and Drug Administration released a copy of the FDA Form 483 issued to the New England Compounding Center (NECC) that produced contaminated steroid injections and triggered an FDA investigation of a multistate fungal meningitis outbreak among patients who received the injections. The FDA observed and has since confirmed contaminated products and listed a number of observations regarding conditions 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 … Read the rest