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...]
WARNING LETTES ISSUED TO COMPANIES MAKING HAND SANITIZERS
FDA WARNS COMPANIES TO STOP MAKING MRSA CLAIMS FOR OVER-THE -COUNTER PRODUCTS (4/20/2011) Comment The FDA recently sent Warning Letters to the four companies listed below for "making unproven prevention claims". ".... the labeling of some of the firms’ hand sanitizing drug products make claims related to preventing infection from E.coli and/or … [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...]
FDA IGNORES CONSIDERATION OF WRITTEN RESPONSES IN DRAFTING WARNING LETTER
CEPHAZONE PHARMA'S (APRIL 25, 2011) INITIAL RESPONSE LACKS SUFFICIENT CORRECTIVE ACTION During our July 12, 2010 to August 26, 2010 inspection of your pharmaceutical manufacturing facility, Cephazone Pharma, LLC, located at 250 E Bonita Avenue, Pomona, CA, investigator(s) from the Food and Drug Administration (FDA) identified significant violations of … [Read more...]
SOUTH DAKOTA PHARMACEUTICAL RECEIVES WARNING LETTER (3/17/11)
FDA CITES DAKOTA LABORATORIES FOR FAILURE TO ADEQUATELY VALIDATE ASEPTIC PROCESS Comment Excerpts and comments from specific violations follow. Please obtain the complete Warning Letter from FDA's web site. CGMP Your firm has not established appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile … [Read more...]
