Monthly Archives: September 2011

MEDIA FILLS FOR VALIDATION OF ASEPTIC PREPARATIONS FOR POSITRON EMISSION TOMOGRAPHY (PET) DRUGS

CDER RELEASES A NEW PET DRAFT GUIDANCE CDER has just released as a DRAFT the following Guidance for Industry, “Media Fills for Validation of Aseptic Preparation for Positron Emission Tomography (PET) Drugs.  The Comment period will be 90 days.  Please … Continue reading

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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 … Continue reading

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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 … Continue reading

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610.12 CBER PROPOSED STERILITY TESTS

PART 610.12— CBER GENERAL BIOLOGICAL PRODUCTS STANDARDS PROPOSED COMMENT Enclosed is the summary of the proposed requirements for the revised CBER 610.12 Sterility Test.  Comments are due by September 19, 2011.  For additional information, please see below for a summary or … Continue reading

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