This blog is written by Mr. Steven C. Schurr, Esq. and focuses on health care law matters that pertain to food and drug law, regulatory compliance, privacy rights, insurance coverage, state and federal disability coverage, patient advocacy issues, and mental health coverage and treatment.
Tuesday, October 23, 2012
FDA's List of Clinics Utilizing Source of Meningitis Outbreak
I should add that the list includes many clinics and hospitals in the Michiana area in Indiana, including Goshen and Elkhart, and in the Chicago metro area. Below is a sample letter that the FDA drafted for clinics that may have provided questionable injections from the rouge pharmacy in New England, who apparently did not follow standard guidelines for sterilization. If you received a questionable injection, you may receive such a letter.
I should add that the list includes many clinics and hospitals in the Michiana area in Indiana, including Goshen and Elkhart, and in the Chicago metro area. Below is a sample letter that the FDA drafted for clinics that may have provided questionable injections from the rouge pharmacy in New England, who apparently did not follow standard guidelines for sterilization. If you received a questionable injection, you may receive such a letter.
ReplyDeletehttp://www.fda.gov/downloads/Drugs/DrugSafety/UCM324538.pdf
Here is the FDA Form 483 resulting from a recent inspection of New England Compounding Pharmacy:
ReplyDeletehttp://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM325980.pdf
http://www.southbendtribune.com/news/sbt-indiana-reports-4th-death-from-meningitis-outbreak-20121105,0,6417314.story
ReplyDeleteA fourth death in Indiana from the outbreak; three deaths in Elkhart County.
ReplyDelete