"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...]
FDA INCREASES VIGILANCE ON ASEPTIC PROCESSING FACILITIES
 B/POR REVIEWS RISING TIDE OF FDA 483s AND WARNING LETTERS AT FIRMS TO INCLUDE BEN VENUE LABS, HOSPIRA AND FORMATECH COMMENT Policy changes and enforcement strategies implemented by the FDA have led to an increase in the number of inspection of sterile manufacturers -- especially injectables. There is greater … [Read more...]
JOINT AUDIT BY UK (MHRA) AND FRENCH (AFSSAPS) MEDICINES REGULATORY AGENCIES TOGETHER WITH FDA HIGHLIGHT ASEPTIC FILLING PROCESS DEFICIENCIES (11/7-11/11)
CHMP RECOMMENDS RECALL OF SELECTED BATCHES MFG AT BEN VENUE SUMMARY A joint GMP inspection of the Ben Venue site, where a number of sterile medicines are manufactured, by the UK and French medicines regulatory agencies together with the US FDA on 7-11 November 2011 highlighted several shortcomings in the quality management system, particularly in relation to the aseptic … [Read more...]
BEN VENUE FAILS TO FOLLOW FDA’s GUIDANCE FOR INDUSTRY RE: STERILE DRUG PRODUCTS (09/04)
A REVIEW OF ADDITIONAL BEN VENUE 483 OBSERVATIONS (5/25/11) COMMENT A review of additional Ben Venue Form FDA 483 Observations suggests that many of these observations relate to either not following or following incorrectly the FDA's Guidance for Industry Sterile Drug Products (September 2004). The Observations that follow include … [Read more...]
BEN VENUE LABORATORIES RECEIVES FORM FDA 483 FOR ASEPTIC PROCESSING ISSUES (5/25/11)
JUST RELEASED 48 OBSERVATIONS MAY BECOME A PRIMER TO COMPLEMENT FDA 2004 ASEPTIC PROCESSING GUIDANCE The FDA released on Friday, October 14, 2011 a total of 48 Observations within a 33 page Form FDA 483 to Ben Venue Laboratories, Inc., Bedford, OH following an inspection of their facilities from May 2 -25, 2011. This should become a "must read" primer and complement to FDA's … [Read more...]
