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 before use. COMMENT 211.065(3) (d) and 21 CFR 211.113(a) discuss the need to test components prior to … [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...]
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...]
