HOSPIRA'S IRUNGATTUKOTTAI FACILITY RECEIVES WARNING LETTER (052813) Recently Ranbaxy settled a $500 million lawsuit with the Dept. of Justice for selling improperly manufactured and tested drugs (see previous Blogs). More recently, Maharashtra-based Wockhardt received an Import ban (see previous Blogs to learn of what other Indian based … [Read more...]
MEDI-FARE DRUG AND HOME HEALTH CENTER, BLACKSBURG, SC RECEIVES WARNING LETTER (3/7/13)
SERIOUS DEFICIENCIES ARE NOTED IN THE PRACTICE OF PRODUCING STERILE DRUGS BACKGROUND Recently the FDA has been criticized for its management of the New England Compounding Center. The following Warning Letter represents one of the first Warning Letters that the Agency has issued in a similar area since the issue of Compounding Pharmacies has become a national … [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...]
TOP 15 BACTERIA REPRESENT 50% OF BACTERIAL ISOLATES IDENTIFIED
ACCUGENIX IDENTIFIED WHAT MICROORGANISMS REPRESENT THE OTHER 50% While having knowledge of the most frequently identified bacteria is informative, it is important to note that these Top 15 bacteria identified from manufacturing environments, as cited in the original post, only represent approximately 50% of the microbes that are identified during routine monitoring and … [Read more...]
