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...]
REVIEW OF SELECTED OBSERVATIONS FROM BEN VENUE FDA 483 (5/25/11)
MEDIA FILL OBSERVATION GATHERS 8 "SUBOBSERVATIONS" COMMENT Enclosed are the initial four Subobservations from the audit surrounding the Media Fill Program. Where possible FDA's 2004 Aseptic Processing Guidance is referenced. OBSERVATION 3 The "Media Fill Program Parameters and Specifications" document #030-SOP-029, and the "Outlining Test Parameters and Specifications … [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...]
PROFESSIONAL DISPOSABLES INTERNATIONAL, INC, ORANGEBURG, NY RECEIVES FORM FDA 483 (7/5/11)
BACILLUS CEREUS RECOVERED FROM APPLICATOR USED TO MANUFACTURE NON-STERILE ALCOHOL PREP PADS OBSERVATION 1 Each lot of a component that is liable for microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use. COMMENT 211.065(3) (d) and 21 CFR 211.113(a) discuss the need to test components prior to … [Read more...]
