ISSUES INCLUDE MOLD GROWTH AT STERILE MANUFACTURING ENTRY AND DEAD AND DECAYING FROGS NEAR THE PRODUCT EXIT DOCK Between October 29 and November 1, 2013, the FDA inspected Marck Biosciences Ltd., Kheda, India. As a consequence of this audit, the FDA issued six extensive Observations. This Blog only reviews Observation 5 (a) and 5 (b). “Your firm failed to maintain the … [Read more...]
BAXTER INITIATES U.S. VOLUNTARY RECALL OF ONE LOT OF PERITONEAL DIALYSIS SOLUTION (3/05/14)
CONTAINER-CLOSURE NON-INTEGRITY APPEARS TO PERMIT MOLD GROWTH COMMENT Baxter International Inc initiated a recall for a single lot of DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose. While the recall is due to non-integrity of the container-closure, it appears that complaints of particulate matter, identified as mold, were growing within the 6000 mL bags from … [Read more...]
