RECALL CONDUCTED DUE TO A POST-RELEASE MANUFACTURING INVESTIGATION Bedford Laboratories, a division of Boehringer-Ingelheim announced on February 12, 2012 a recall for three lots of Cytarabine for Injection, USP. This “voluntary” market recall, announced with the knowledge of the FDA is being conducted due to a post-release investigation of the manufacturing area which … [Read more...]
BEN VENUE RECEIVES YET ANOTHER FORM FDA 483 (12/2/11)
TWELVE PAGE, TEN ITEM 483 COMPLEMENTS 483 ISSUED EARLIER IN 2011 Ben Venue Laboratories received a second audit by four FDA investigators from Nov 7 thru Dec 2, 2011 and received a twelve page Form FDA 483 with ten Observations. While several of the Observations were similar to those previously received in the May 2011 audit, new Observations were also noted as part of the … [Read more...]
BEN VENUE LABORATORIES — VOLUNTARY SHUTDOWN (11/19/11)
SHUTDOWN OCCUS AS RESULT OF SIGNIFICANT MANUFACTURING AND QUALITY CONCERNS On November 19, 2011, Ben Venue Laboratories, Inc. (“BVLâ€) announced the voluntary shutdown of manufacturing and distribution at its site in Bedford, Ohio due to significant manufacturing and quality concerns. BVL’s decision to shut down is a result … [Read more...]
