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 Guidance for Industry, Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice, September 2004.
Over the next several weeks comments on these various Observations will be reviewed within my Blog. However, to obtain immediate information, please visit the site listed below.
http://www.fda.gov/downloads/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/UCM275843.pdf
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