RECALL CONDUCTED DUE TO A POST-RELEASE MANUFACTURING INVESTIGATION Bedford Laboratories, a division of Boehringer-Ingelheim announced on February 12, 2012 a recall for three lots of Cytarabine for Injection, USP. This “voluntary” market recall, announced with the knowledge of the FDA is being conducted due to a post-release investigation of the manufacturing area which … [Read more...]
H&P’s ANATOMY OF A CONSENT DECREE (01/24/12)
H&P INDUSTRIES FULFILLS ITS INITIAL OBLIGATIONS AND RECEIVES RETURNED BOND H&P Industries has a recent history of receiving significant Form FDA 483s from the FDA. The consequence of these various recalls and 483s ultimately led to a seizure of raw materials, in-process product and final product by U.S. Marshalls. Subsequent to that H&P Industries entered into a … [Read more...]
LEARN ABOUT THE FORM FDA 483s THAT LED TO THE NOVARTIS RECALL (1/08/12)
SPECIFIC OBSERVATIONS POINT TO THE EVENTUAL LINCOLN, NE RECALL Novartis Consumer Health, Inc. (NCH) received a Form FDA 483 containing 10 Observations representing 23 pages on January 20, 2012. Several of the Observations were similar to those received in July 2011. Observation 1 is the most inclusive and reads as follows: “OBSERVATION 1 QUALITY SYSTEM: Your Quality Unit … [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...]
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...]
