All avoidable.
The people in Braine manufacturing knew there was a problem since forever and decided to ignore it and pray for the best. FDA saw the issue and the "fix", didn't buy the BS during the inspection and didn't by the BS response to the 483 that was senior management (QA and business) endorsed. All this is supposed to be secret but the company in buzzing with talk coming from Belgium
This issue was known about and entirely fixable and preventable....wonder who will get fired and how long the delay will be and can the external consultants put lipstick on this pig.
