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CDER RELEASES A NEW PET DRAFT GUIDANCE CDER has just released as a DRAFT the following Guidance for Industry, "Media Fills for Validation of Aseptic Preparation for Positron Emission Tomography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 visit  http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273766.pdf to obtain this DRAFT … [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...]

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 visit the enclosed web site for the full release … [Read more...]