A REVIEW OF ADDITIONAL BEN VENUE 483 OBSERVATIONS (5/25/11) COMMENT A review of additional Ben Venue Form FDA 483 Observations suggests that many of these observations relate to either not following or following incorrectly the FDA's Guidance for Industry Sterile Drug Products (September 2004). The Observations that follow include … [Read more...]
TOP 15 BACTERIA REPRESENT 50% OF BACTERIAL ISOLATES IDENTIFIED
ACCUGENIX IDENTIFIED WHAT MICROORGANISMS REPRESENT THE OTHER 50% While having knowledge of the most frequently identified bacteria is informative, it is important to note that these Top 15 bacteria identified from manufacturing environments, as cited in the original post, only represent approximately 50% of the microbes that are identified during routine monitoring and … [Read more...]
BEST METHOD TO DETERMINE THE IDENTIFICATION OF A MICROORGANISM
DIFFERENTIATION BETWEEN PHENOTYPIC AND GENOTYPIC IDENTIFICATION MECHANISMS Recently, a Blog was published that identified the fifteen most common bacterial isolates identified by Accugenix, Inc, Newark, DE during 2010. This Blog created an interest in other related areas to include the best methods to assure a definitive identification of an isolated bacterium. In a poster … [Read more...]
BACTERIA MOST OFTEN SUBMITTED FOR IDENTIFICATION TESTING DURING 2010
FREQUENTLY ENCOUNTERED BACTERIAL ENVIRONMENTAL ISOLATES Microbiological consulting professionals  are often requested to assist Clients with the identification of various environmental microorganisms to include bacteria that are isolated from their various HVAC and Utility Systems during facility commissioning and on-going operations. These … [Read more...]
