Site was closed (maybe partly because of this). Senior manager was Dave Shepherd, now of Thermo Fisher Scientific...
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Hello FDA, ripe for an audit?
Don't know if it was ever made public but Viamet were mightily annoyed having raised $60m in private capital and publicly announced the start date of the trial. It was well known by local senior management that production technicians were taking shortcuts in order to save time during nightshifts; usually to enable four to five hours sleep during the shift. In this case, an essential reagent was not added yet the technician recorded the addition in the Batch Manufacturing Record. An excuse was made that he was assisting with an incident in a separate plant - where (I believe) Dibromofluoromethane/Bromofluoromethane had leaked to ground/atmosphere (yes, really) - and having pre-filled the BMR, then forgot to carry out the addition. However, it was alleged that the release incident took place at a greatly different time to the addition entry in the BMR (in my experience of the shift concerned, the BMR would not reflect true work-up/addition/reaction times etc. as these would be compressed at the start of the shift but falsely documented as occuring later on to disguise the unmanned part of the shift. The technician received a written warning.
Wow, is this publically announced
cGMP fail. How/Why?