EXAMINE HOW THE REVISED USP<1116> RELATES TO THESE OBSERVATIONS FIRM IS PLACED UNDER FDA IMPORT ALERT Hemofarm A.D., Vrsac, Serbia recently received a four Observation Warning Letter for unreliable environmental (to include microbiological) monitoring data. Several of the CGMP violations listed in their letter include … [Read more...]
AMERIDOSE, LLC RECEIVES 15 OBSERVATIONS AS PART OF FORM FDA 483 (11/09/12)
SISTER COMPANY OF NECC RECEIVES TWENTY PAGE 483 CONTAINING SEVERAL REPEAT OBSERVATIONS COMMENT The FDA conducted an inspection of Ameridose, LLC, Westborough, MA from October 10 through November 9, 2012. The investigation, involved fourteen Investigators and three microbiologists including one microbiologist from CDER. A total of fifteen Observations including several … [Read more...]
INTERNATIONAL LABORATORIES (CANADA) LTD RECEIVES FDA (CDER) WARNING LETTER (10/23/12)
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...]
