A RESPONSE TO YOUR QUERIES RE: FREQUENT TOPICS OF INTEREST Periodically, I am asked what are the most frequent topics which interest the reader. Because the reader has so many varied interests, it is difficult to determine this without retrospectively reviewing the data. I have summarized below the “top six” topics that have been viewed since the beginning of 2012. You may … [Read more...]
CURRENT CONTRACT MANUFACTURING OPERATION (CMO) REGULATORY ISSUES (3/15/12)
FEATURING A SUMMARY OF BEN VENUE ISSUES Policy changes and enforcement strategies implemented by the FDA have led to an increase in the number of inspection of both Contract Manufacturing Operations (CMOs) and in-house sterile manufacturers — especially injectables. There has been a greater oversight and detailed review of all protocols and processes. Any issue or potential … [Read more...]
H&P’s ANATOMY OF A CONSENT DECREE (01/24/12)
H&P INDUSTRIES FULFILLS ITS INITIAL OBLIGATIONS AND RECEIVES RETURNED BOND H&P Industries has a recent history of receiving significant Form FDA 483s from the FDA. The consequence of these various recalls and 483s ultimately led to a seizure of raw materials, in-process product and final product by U.S. Marshalls. Subsequent to that H&P Industries entered into a … [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...]
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...]
