COMMENT Often during webinars and seminars, the question is raised regarding the specifications for Purified Water (PW) and Water for Injection (WFI). The USP has responded with an explanation as part of their series on Microbiological Frequently Asked Questions (FAQ). Please read below to learn more about how one should develop … [Read more...]
FRANCK’S PHARMACY RECALLS ALL STERILE HUMAN AND VETERINARY PRESCRIPTIONS FROM NOV 21, 2011 TO MAY 21, 2012
ENVIRONMENTAL SAMPLING OF CLEAN ROOM REVEALED PRESENCE OF MICROORGANISMS AND FUNGAL GROWTH BY FDA. WHAT HAPPENED TO USP <797>? Franck's Pharmacy, Ocala, Florida initiated a recall of all sterile human and veterinary prescriptions from November 21, 2011 through May 21, 2012. This recall follows an earlier recall (May 2, 2011 Notice of Recall, … [Read more...]
PDI, ORANGEBURG, NY IS RECALLING 285 MILLION NON-STERILE ALCOHOL PADS AS PER FDA ENFORCEMENT REPORT (10/5/11)
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 objectionable, over 285 million packets are being recalled. Non-Sterile Alcohol Prep … [Read more...]
SECOND WIPE-MAKER ISSUES RECALL AFTER BACTERIA DETECTED
NON-STERILE WIPES RECALLED ON SEPTEMBER 16, 2011 FOLLOWING DISCOVERY OF LOW LEVELS OF BACILLUS CEREUS COMMENT Bacillus cereus was recently identified within non-sterile alcohol prep wipes manufactured by Professional Disposables International Inc (PDI), Orangeburg, NY. The recall of five lots are similar to the recalls of sterile and non-sterile wipes from H & P Industries … [Read more...]
MIRAMAR COSMETICS RECEIVES WARNING LETTER (AUGUST 18, 2011)
WARNING LETTER IS RECEIVED FOR REPEAT VIOLATIONS AND OBJECTIONABLE (SPECIFIED) MICROORGANISMS COMMENT Miramar Cosmetics of Doral, Florida received a Warning Letter for repeat violations from 2007, the presence of objectionable (“specified”) microorganisms, responding after 15 business days after the Form FDA 483 was issued and the manufacturing of drugs without an approved … [Read more...]
