NO FDA EXPORT BAN (REFUSAL OF ADMISSION) IS ISSUED The FDA conducted an inspection of International Laboratories from February 13 – 16, 2012 at their facilities in Calgary, Alberta. While the Company responded within 15 business days, the responses to the audit were unsatisfactory and a Warning Letter containing five Observations was … [Read more...]
FDA REPORTS VOLUNTARY RECALL OF ALL AMERIDOSE DRUG PRODUCTS (10/31/12)
ON-GOING INSPECTION SUGGESTS LACK OF STERILITY ASSURANCE OF INJECTABLE PRODUCTS The U.S. Food and Drug Administration announced today that Ameridose, LLC, based in Westborough, Mass., and sharing common management with NECC,  is voluntarily recalling all of its unexpired products in circulation. Products from Ameridose can be identified by markings that … [Read more...]
NEW ENGLAND COMPOUNDING CENTER RECEIVES FDA 483 (10/26/12)
FDA INVESTIGATORS CONFIRM CONTAMINATION IN 50 OF 50 VIALS TESTED COMMENT The FDA issued its initial Form FDA 483 regarding the New England Compounding Center located in Framingham, MA. The eight page, five item 483 describes the initial findings of their audit. The Company now has 15 business days to submit its response to the FDA. Of … [Read more...]
PRELIMINARY REPORT OF NEW ENGLAND COMPOUNDING CENTER ISSUED BY MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH (DPH) (10/23/12)
NOTES FAILURE TO COMPLY WITH USP <797> AND STATE LAWS AND REGULATIONS BACKGROUND “Pharmacy Compounding†involves modifying commercially available products to meet the requirements of an individual patient based upon a prescription from a licensed provider. Within the State of Massachusetts, a total of 25 pharmacies meet … [Read more...]
NEW ENGLAND COMPOUNDING CENTER (NECC) POTENTIALLY CONTAMINATED MEDICATION: FUNGAL MENINGITIS OUTBREAK
Out of an abundance of caution, FDA is taking the additional step of recommending that health care professionals and consumers not use any product that was produced by NECC at this time. [UPDATED 10/06/2012] On October 4, 2012, the CDC and FDA recommended that all health care professionals cease use and remove from their pharmaceutical inventory any product produced by the New … [Read more...]
