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 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...]
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...]
