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...]