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...]
AUROBINDO PHARMA LIMITED, UNITS III AND VI, RECEIVE WARNING LETTER (MAY 20, 2011)
 AUROBINDO PHARMA RECEIVES IMPORT BAN FOLLOWED BY WARNING LETTER  -- AN UNUSUAL SEQUENCE OF EVENTS COMMENT The receiving of an Import Ban prior to receiving a Warning Letter has not been a common occurrence. However, because of the FDA's recent and previous audits, and the lack of continuing compliance, … [Read more...]
PHARMACEUTICAL COMPANY JELFA SA (POLAND) RECEIVES WARNING LETTER (7/14/11) PART II
JELFA SA FAILS TO FOLLOW FDA'S ASEPTIC PROCESSING GUIDANCE FOR INDUSTRY (SEPTEMBER 2004)  2. Your firm has not established appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile [21 C.F.R. § 211.113(b)]. For … [Read more...]
