CDER NAMES THESE TEN (21 CFR 211) Comment The following represent those most frequent Observations that CDER posted for fiscal year 2010 based on a total of 646 FDA Form 483. REFERENCE             … [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...]
FDA ENTERS CONSENT DECREE WITH H AND P INDUSTRIES (TRIAD GROUP)
TRIAD GROUP MUST AWAIT AN ACCEPTABLE QUALITY ASSURANCE AND QUALITY CONTROL PROGRAM BEFORE RESUMING MANUFACTURING AND DISTRIBUTION Comment The FDA entered into a Consent Decree of Condemnation, Forfeiture and Permanent Injunction against H&P Industries that would prevent them from manufacturing and distributing products from their Hartland, WI facility. Under the decree, … [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...]
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...]
