Ed,or maybe Loan,could you summarize where this conversation is pointing to?
To what insight is this leading to?
This isn't criticiem,just trying to understand what tree you guys are barking up?
As far as I'm concerned,it's pretty simple.
Here's your culprit:
"....new FDA regulation regarding product identification and registration, the so-called FDA UDI initiative, and has had to
alter packaging and its establishment registrations to accommodate this change. Shipments using the new FDA UDI
packaging began on September 22, 2016. Changeover to the FDA UDI product packaging format has necessitated a
withdrawal of non-UDI inventory from stock, valued at $0 due to its obsolescence. This process began in the period
ended June 30, 2016 and September 30, 2016 and are reflected herein. The company expects to sell this obsolete but
suitable product in International markets. "
Although the guidelines have been out for 2 years(see my ink in previous posts),it appearsDECN provided incorrect specifications to whomever was responsible for the production of the product which was written off. Since it was DECN that had to write it off,that sends a message it wasn't a mistake they could go back to the CM for recovery of costs for,thus their write-off(apparently they expect to sell this offshore at some point,but with no guarantees...so it was a 100% loss...recorded at what the CM billed them for).
Two things...
Apparently the product couldn't be sent out and reworked(?). If it was simply packaging issues,couldn't it be repackaged? Where the strips bad?
Secondly,with the money being spent on Consultants and especially in context of the FDA missteps that occured under DECN's watch which almost killed Genstrip,a compliance
consultant would have been hired,or if incompetent,they would own the mistake. But DECN has clearly taken ownership of this,so it was under their watch.
UDI compliance is pretty basic stuff. It's a starter.
Unless I'm missing something,This was a DECN "misstep",which proved very costly,plain and simple.
Scoop
