Monthly Archives: October 2011

BEN VENUE LABORATORIES RECEIVES FORM FDA 483 FOR ASEPTIC PROCESSING ISSUES (5/25/11)

Posted on October 27, 2011 by Barry A. Friedman, PhD LLC

JUST RELEASED 48 OBSERVATIONS MAY BECOME A PRIMER TO COMPLEMENT FDA 2004 ASEPTIC PROCESSING GUIDANCE The FDA released on Friday, October 14, 2011  a total of 48  Observations within a 33 page Form FDA 483 to Ben Venue Laboratories, Inc., … Continue reading →

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INSIGHT PHARMACEUTICALS ISSUE VOLUNTARY NATIONWIDE RECALL DUE TO BACTERIAL CONTAMINATION

Posted on October 24, 2011 by Barry A. Friedman, PhD LLC

RECALL TO CONSUMER LEVEL BECAUSE OF POSSIBLE BURKHOLDERIA CEPACIA COMMENT Insight Pharmaceuticals recalled 34,092 bottles of Nostrilla Nasal Decongestant nasal spray because it may contain the bacteria Burkholderia cepacia.  This bacterium, known as a “specified” microorganism, has historically been a periodic contaminant of nasal … Continue reading →

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RECALL OF PDI NON-STERILE ALCOHOL WIPES RAISES ADDITIONAL QUESTIONS SAYS MSNBC.COM

Posted on October 19, 2011 by Barry A. Friedman, PhD LLC

FRIEDMAN QUOTED AS SAYING THAT NON-STERILE GAUZE PADS SHOULD NOT BE USED WITH INJECTABLES COMMENT  JoNel Aleccia, Health Writer for MSNBC.com, questions the use of non-sterile wipes based upon a massive recall of potentially contaminated alcohol prep products by a second manufacturer.  … Continue reading →

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PROFESSIONAL DISPOSABLES INTERNATIONAL, INC, ORANGEBURG, NY RECEIVES FORM FDA 483 (7/5/11)

Posted on October 12, 2011 by Barry A. Friedman, PhD LLC

BACILLUS CEREUS RECOVERED FROM APPLICATOR USED TO MANUFACTURE NON-STERILE ALCOHOL PREP PADS OBSERVATION 1 Each lot of a component that is liable for microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests … Continue reading →

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PDI, ORANGEBURG, NY IS RECALLING 285 MILLION NON-STERILE ALCOHOL PADS AS PER FDA ENFORCEMENT REPORT (10/5/11)

Posted on October 7, 2011 by Barry A. Friedman, PhD LLC

NON-STERILE WIPES FOUND TO BE CONTAMINATED BY FDA SAMPLING AND ANALYSES  COMMENT FDA sampling and analyses of non-sterile alcohol prep pads were found to be contaminated with Bacillus cereus. Based on USP<61> and <62> wherein “specified” in-house microorganisms are considered … Continue reading →

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