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...]
BEN VENUE DETERMINES SIGNIFICANT REMEDIATION REQUIRED AT ITS BEDFORD, OHIO FACILITIES
"NORTH" FACILITY MAY NOT BE AVAILABLE FOR MFG OF STERILE INJECTABLES BEFORE 4th QUARTER 2012 COMMENT Ben Venue Laboratories issued an early "Christmas gift" press release on Friday, December 23 wherein they announced the decision to extend the voluntary suspension of manufacturing at its Bedford, OH facility. Ben Venue has determined that it can no longer both … [Read more...]
