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...]
H and P Industries Lawsuit Ties Tainted Wipes to Twin’s Brain Damage
MSNBC Reports On On-Going Rare Bacterial Infection Stumped Experts Until News Of Contaminated Products Surfaced For nearly four years, a bacterial infection that left a Seattle-area newborn with severe brain damage while his twin brother developed normally has remained a medical mystery, traumatizing his family and stumping local and national disease experts. Myles Massey, … [Read more...]
