FAILURE OF THE ARC TO MEET REQUIREMENTS YIELDS OVER 9 MILLION DOLLAR FINE From April through October 2010, United States Food and Drug Administration (FDA) investigators inspected sixteen American National Red Cross (ARC) Blood Services facilities and observed significant violations of the law, regulations, and the Amended Consent Decree of Permanent Injunction, entered on … [Read more...]
VAGINA COSMETICS RECALLED FOR CONTAINING MICROORGANISMS AND BENZOCAINE
EFFECT OF MICROBIAL CONTAMINATION DIFFICULT TO ASSESS COMMENT USA Far Ocean Group issued a voluntary recall following FDA's laboratory analyses of "Vagifresh Gel" and "Vagifresh Ball". The former contained benzocaine, while the later contained bacteria from a number of species to include Staphylococcus lentus, S. sciuri, Bacillus lentus, Alloiococcus otitis, … [Read more...]
PHARMA EXPECTATIONS IN 2012
IS THE GLASS HALF FULL OR HALF EMPTY COMMENT Paul Thomas from pharmamanufacturing has submitted a list of what 13 "experts" believe to be occurring during 2012. Take a look at these to determine if you concur, disagree or have other thoughts to add. What Can Pharma Expect in 2012? The Glass is Half Full (and Half Empty) Submitted by pharmamanufacturing on Thu, … [Read more...]
CDER GUIDANCES 2011– NEW/REVISED/WITHDRAWN
During 2011 CDER released a number of new Guidance for Industry documents. Many of these documents are quite difficult to locate within knowing the exact name of the document. These documents include the very widely publicized Process Validation (January 2011), several relating to PET (Positron Emission Tomography) products and their approvals, as well … [Read more...]
BEN VENUE DETERMINES SIGNIFICANT REMEDIATION REQUIRED AT ITS BEDFORD, OHIO FACILITIES
"NORTH" FACILITY MAY NOT BE AVAILABLE FOR MFG OF STERILE INJECTABLES BEFORE 4th QUARTER 2012 COMMENT Ben Venue Laboratories issued an early "Christmas gift" press release on Friday, December 23 wherein they announced the decision to extend the voluntary suspension of manufacturing at its Bedford, OH facility. Ben Venue has determined that it can no longer both … [Read more...]
